Staple, Implantable
FDA product code GDW · Class II (moderate risk) · 21 CFR 878.4750 · General, Plastic Surgery
283510(k) clearances
0PMA approvals
209recalls
Implantimplanted device
Manufacturers
- Ethicon Endo-Surgery, Inc. 44
- United States Surgical, A Division of Tyco Healthc 28
- Covidien LLC 27
- Power Medical Interventions, Inc. 22
- C.R. Bard, Inc. 10
- ETHICON, Inc. 10
- Covidien, Formerly US Surgical A Divison of Tyco H 8
- Ezisurg Medical Co., Ltd. 5
- Incisive Surgical, Inc. 5
- Cardica, Inc. 5
- Lexington Medical, Inc. 5
- Changzhou Kangdi Medical Stapler Co., Ltd. 4
- Via Surgical , Ltd. 4
- B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. 3
- Reach Surgical, Inc. 3
- Biopsys Medical, Inc. 3
- Std Mfg., Inc. 3
- Fengh Medical Co., Ltd. 3
- 3M Medical Products Group 2
- American Heyer Schulte 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/11/2026SE |
| K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray…GDW · Traditional | Covidien (Part of Medtronic) | 04/10/2026SE |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 10/28/2024SE |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm…GDW · Special | Fengh Medical Co., Ltd. | 10/04/2024SE |
| K222487 | Anika Tissue Tack Fixation SystemGDW · Traditional | Anika Therapeutics, Inc. | 05/08/2023SE |
| K222210 | AEON Endoscopic StaplerGDW · Traditional | Lexington Medical, Inc. | 04/21/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | Ethicon Endo-Surgery | 03/15/2023SE |
| K211197 | Disposable Endoscopic Cutter Stapler and CartridgeGDW · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 01/19/2023SE |
| K221771 | EEA Circular Stapler with Tri-Staple TechnologyGDW · Traditional | Covidien | 11/30/2022SE |
| K222641 | Signia Small Diameter Reloads Including Regular (Round) Tip VersionGDW · Traditional | Covidien | 11/29/2022SE |
| K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture…GDW · Traditional | Covidien | 09/30/2022SE |
| K221013 | GIA Auto Suture Stapler with DST Series TechnologyGDW · Special | Covidien | 05/05/2022SE |
| K221006 | GIA Stapler with Tri-Staple TechnologyGDW · Special | Covidien | 04/29/2022SE |
| K221005 | EEA Circular Stapler with Tri-Staple TechnologyGDW · Special | Covidien | 04/29/2022SE |
| K211811 | Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…GDW · Traditional | Wuxi Beien Surgery Device Co., Ltd. | 03/03/2022SE |
| K211458 | Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…GDW · Traditional | Ningbo Verykind Medical Device Co., Ltd. | 12/30/2021SE |
| K201934 | Surgimatix Absorbable Fixation SystemGDW · Traditional | Surgimatix, Inc. | 10/01/2021SE |
| K210909 | easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseGDW · Traditional | Ezisurg Medical Co., Ltd. | 06/24/2021SE |
| K201639 | Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler…GDW · Traditional | Beijing Biosis Healing Biolog Ical Technology… | 05/27/2021SE |
| K202709 | Disposable Powered Endoscopic Linear Cutting Staplers and CartridgesGDW · Traditional | Ningbo Verykind Medical Device Co., Ltd. | 05/18/2021SE |
| K210278 | Titan SGSGDW · Traditional | Standard Bariatrics | 04/28/2021SE |
| K200320 | Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…GDW · Traditional | M/s. Meril Endo Surgery Private Limited. | 02/05/2021SE |
| K202507 | EEA Circular Stapler with Tri-Staple TechnologyGDW · Traditional | Covidien | 01/21/2021SE |
| K203117 | TissueTak deviceGDW · Traditional | Via Surgical , Ltd. | 01/07/2021SE |
| K202467 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & ReloadsGDW · Special | Fengh Medical Co., Ltd. | 12/14/2020SE |
| K202701 | GIA Stapler with Tri-Staple TechnologyGDW · Special | Covidien | 12/07/2020SE |
| K202864 | Tri-Staple 2.0 ReloadsGDW · Special | Covidien | 10/28/2020SE |
| K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm…GDW · Special | Ethicon Endo-Surgery, LLC | 10/15/2020SE |
| K201882 | AEON Endoscopic StaplerGDW · Traditional | Lexington Medical, Inc. | 10/09/2020SE |
| K201280 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL SealedGDW · Special | Ethicon Endo-Surgery, LLC | 07/27/2020SE |
| K201672 | Signia Stapler (with new software)GDW · Special | Covidien | 07/17/2020SE |
| K200420 | Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green…GDW · Traditional | Ethicon Endo-Surgery, LLC | 06/29/2020SE |
| K192720 | GIA Stapler with Tri-Staple TechnologyGDW · Traditional | Covidien | 03/13/2020SE |
| K192330 | EEA Circular Stapler with Tri-Staple TechnologyGDW · Traditional | Covidien | 01/23/2020SE |
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolGDW · Traditional | Datascope Corp. | 12/26/2019SE |
| K182476 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & ReloadsGDW · Traditional | Fengh Medical Co., Ltd. | 12/18/2019SE |
| K190331 | Applied Medical Laparoscopic Linear CutterGDW · Traditional | Applied Medical Resources Corporation | 11/22/2019SE |
| K192566 | Reach and CQ'ENCE Circular StaplersGDW · Special | Reach Surgical, Inc. | 10/17/2019SE |
| K191070 | Signia Small Diameter ReloadsGDW · Traditional | Covidien | 09/04/2019SE |
| K191287 | OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners…GDW · Special | Davol Inc., Subsidiary of C.R. Bard | 07/16/2019SE |
| K182217 | Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single UseGDW · Traditional | Ezisurg (Suzhou) Medical Co., Ltd. | 04/16/2019SE |
| K182475 | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads…GDW · Traditional | Covidien | 03/14/2019SE |
| K181668 | FasTouch Absorbable Fixation SystemGDW · Traditional | Via Surgical , Ltd. | 03/13/2019SE |
| K183477 | easyPPHTM Hemorrhoidal Stapler for Single UseGDW · Traditional | Ezisurg Medical Co., Ltd. | 02/11/2019SE |
| K183435 | Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and BlackGDW · Traditional | Ethicon Endo-Surgery, LLC | 02/06/2019SE |
| K181657 | easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular…GDW · Traditional | Ezisurg Medical Co., Ltd. | 02/01/2019SE |
| K180175 | SignalMark Lung Biopsy Site MarkerGDW · Traditional | View Point Medical, Inc. | 12/07/2018SE |
| K182380 | AEON Endoscopic StaplerGDW · Traditional | Lexington Medical, Inc. | 11/28/2018SE |
| K181653 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL SealedGDW · Traditional | Ethicon Endo-Surgery, LLC | 09/18/2018SE |
| K181620 | Endoscopic Linear Cutting Staplers and Loading Units for Single UseGDW · Traditional | Ezisurg (Suzhou) Medical Co., Ltd. | 09/18/2018SE |
| K173270 | Tri-Staple 2.0 Reinforced ReloadGDW · Traditional | Covidien | 02/20/2018SE |
| K172361 | EEA Circular Stapler with Tri-Staple TechnologyGDW · Traditional | Covidien | 02/16/2018SE |
| K173443 | AEON Endoscopic StaplerGDW · Traditional | Lexington Medical, Inc. | 02/01/2018SE |
| K172960 | easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…GDW · Traditional | Ezisurg Medical Co., Ltd. | 12/21/2017SE |
| K172561 | Disposable Circular StaplerGDW · Special | Changzhou Kangdi Medical Stapler Co., Ltd. | 12/05/2017SE |
| K172538 | Disposable Linear Stapler, Disposable Linear CutterGDW · Special | Changzhou Kangdi Medical Stapler Co., Ltd. | 11/30/2017SE |
| K171589 | AEON Endoscopic StaplerGDW · Traditional | Lexington Medical, Inc. | 11/17/2017SE |
| K171561 | Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload…GDW · Traditional | Dextera Surgical, Inc. | 08/28/2017SE |
| K162707 | Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…GDW · Traditional | Golden Stapler Surgical Co., Ltd. | 07/14/2017SE |
| K170278 | OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners…GDW · Traditional | C.R. Bard, Inc. | 05/31/2017SE |
| K163523 | ECHELON CIRCULAR Powered StaplerGDW · Traditional | Ethicon Endo-Surgery, LLC | 04/18/2017SE |
| K163698 | OptiFix Open Absorbable Fixation System - 20 absorbable fastenersGDW · Traditional | C.R. Bard, Inc. | 04/11/2017SE |
| K162947 | Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…GDW · Traditional | Chongqing Qmi Surgical Co., Ltd. | 03/03/2017SE |
| K170348 | Signia Four-Bay Smart Charger (to be used with Signia Stapler)GDW · Special | Covidien | 03/02/2017SE |
| K162710 | Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…GDW · Traditional | Tgs Medical Co., Ltd. | 02/09/2017SE |
| K163454 | ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH…GDW · Special | Ethicon Endo-Surgery, LLC | 01/05/2017SE |
| K160969 | ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerGDW · Traditional | Shinemed, LLC | 12/12/2016SE |
| K163098 | Tri-Staple 2.0 Intelligent CartridgeGDW · Special | Covidien, LLC | 12/05/2016SE |
| K161757 | Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…GDW · Traditional | Victor Medical Instruments Co., Ltd. | 12/05/2016SE |
| K161905 | Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable…GDW · Traditional | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 11/17/2016SE |
| K162252 | FasTouch Fixation SystemGDW · Special | Via Surgical , Ltd. | 11/14/2016SE |
| K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadGDW · Traditional | Cardica, Inc. | 07/20/2016SE |
| K160900 | CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure…GDW · Traditional | C.R. Bard, Inc. | 05/31/2016SE |
| K160176 | Signia StaplerGDW · Traditional | Covidien | 04/26/2016SE |
| K153202 | iMESH TackerGDW · Special | Thd Lap | 03/24/2016SE |
| K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmGDW · Special | Ethicon Endo-Surgery, LLC | 03/22/2016SE |
| K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter…GDW · Traditional | Cardica, Inc. | 01/15/2016SE |
| K152618 | PANTHER Cutter StaplerGDW · Traditional | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 11/12/2015SE |
| K151659 | ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable TacksGDW · Special | Covidien, LLC | 07/17/2015SE |
| K142577 | PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsGDW · Traditional | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 06/11/2015SE |
| K151163 | Signia Loading Unit, Tri-Staple 2.0 CartridgeGDW · Special | Covidien, LLC | 05/29/2015SE |
| K150026 | Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/18/2015SE |
| K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix…GDW · Traditional | C.R. Bard, Inc. | 03/12/2015SE |
| K142808 | CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation…GDW · Traditional | C.R. Bard, Inc. | 03/09/2015SE |
| K143129 | easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)GDW · Traditional | Ezisurg Medical Co., Ltd. | 01/29/2015SE |
| K141952 | Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon…GDW · Traditional | Ethicon Endo-Surgery, Inc. | 11/24/2014SE |
| K141097 | CSC Series Intraluminal Stapler for Single UseGDW · Traditional | Touchstone International Medical Science Co., Ltd. | 09/26/2014SE |
| K141367 | LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC…GDW · Traditional | Touchstone International Medical Science Co., Ltd. | 07/25/2014SE |
| K140560 | Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon…GDW · Traditional | Ethicon Endo-Surgery, LLC | 04/22/2014SE |
| K140609 | Reliatack Articulating Reloadable Fixation Device with Standard Purchase Absorble TacksGDW · Special | Covidien | 04/09/2014SE |
| K131563 | Subq It! Bioabsorbable Skin Closure SystemGDW · Traditional | Opus Ksd, Inc. | 04/09/2014SE |
| K132698 | Fastouch Fixation SystemGDW · Traditional | Via Surgical , Ltd. | 03/14/2014SE |
| K140118 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeGDW · Special | Cardica, Inc. | 02/25/2014SE |
| K140170 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeGDW · Special | Cardica, Inc. | 02/19/2014SE |
| K132472 | Justright 5MM Stapler, Justright 5MM ReloadGDW · Traditional | Justright Surgical, LLC | 02/11/2014SE |
| K133938 | Endo Gia Reinforced Reload with Tri-Staple TechnologyGDW · Special | Covidien | 01/22/2014SE |
| K133499 | Suzhou Beinuo Surgical Staplers - Circular Staplers for Single Use, Hemorrhoidal…GDW · Traditional | Suzhou Beinuo Medical Equipment Co. , Ltd. | 01/14/2014SE |
| K132669 | Proxifast Absorbable StapleGDW · Traditional | Surgimatix, Inc. | 01/13/2014SE |
| K133762 | Endo Gia(Tm) Extra Long AdapterGDW · Special | Covidien, LLC | 01/08/2014SE |
| K132581 | Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…GDW · Traditional | Cardica, Inc. | 01/07/2014SE |
| K130738 | Endoscopic Linear Cutting Staplers with Single Use Loading UnitsGDW · Traditional | Nanjing Maidixin Medical Device Co., Ltd. | 12/13/2013SE |
| K132134 | Optifix Absorbable Fixation SystemGDW · Traditional | C.R. Bard, Inc. | 12/02/2013SE |
| K132493 | Endo Gia Radial Reload with Tri-Staple TechnologyGDW · Special | Covidien, LLC | 10/23/2013SE |
| K131663 | Echelon Endoscopic Linear Cutter Reload, BlackGDW · Traditional | Ethicon Endo-Surgery, LLC | 10/18/2013SE |
| K131637 | Rotation Medical Soft Tissue Staple (RMST Staple)GDW · Traditional | Rotation Medical, Inc. | 07/12/2013SE |
| K131511 | Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…GDW · Traditional | Changzhou Sinolinks Medical Innovation Co., Ltd. | 07/05/2013SE |
| K131705 | Endo Gia Radial Reload with Tri-Staple TechnologyGDW · Special | Covidien, Formerly US Surgical A Divison of Tyco H | 07/01/2013SE |
| K131303 | Disposable Circular StaplerGDW · Traditional | Changzhou City Zhiye Medical Devices Institute Co. | 06/11/2013SE |
| K130717 | Endo Gia ReloadGDW · Special | Covidien, Formerly US Surgical A Divison of Tyco H | 04/18/2013SE |
| K130653 | Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60 Powered…GDW · Special | Ethicon Endo-Surgery, LLC | 03/29/2013SE |
| K123114 | Ethicon Securestrap Open Absorbable Strap Fixation DeviceGDW · Traditional | ETHICON, Inc. | 02/05/2013SE |
| K122781 | Reliamax Gastrointestinal Anastomosis and ReloadGDW · Traditional | Covidien, Formerly US Surgical A Divison of Tyco H | 02/05/2013SE |
| K123718 | Permasorb Disposable Fixation DeviceGDW · Special | C.R. Bard, Inc. | 01/22/2013SE |
| K123318 | Idrive Ultra Powered Handle and Endo Gia AdapterGDW · Special | Covidien, Formerly US Surgical A Divison of Tyco H | 12/18/2012SE |
| K123109 | Absorbatack 5MM Single Use Absorbable Fixation DeviceGDW · Special | Covidien | 10/23/2012SE |
| K121510 | Idrive Ultra Powered Handle Endo Gia AdapterGDW · Traditional | Covidien, Formerly US Surgical A Divison of Tyco H | 07/25/2012SE |
| K121600 | Echelon 60 Endoscpic Linear Cutter Reload, WhiteGDW · Traditional | Ethicon Endo-Surgery, LLC | 07/16/2012SE |
| K121474 | Disposable Linear Stapler, Disposable Linear CutterGDW · Traditional | Changzhou Kangdi Medical Stapler Co., Ltd. | 07/16/2012SE |
| K120179 | Reach Surgical StaplersGDW · Traditional | Reach Surgical, Inc. | 05/23/2012SE |
| K120373 | Insorb Absorbalbe StapleGDW · Special | Incisive Surgical, Inc. | 03/16/2012SE |
| K120258 | Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…GDW · Traditional | Covidien, Formerly US Surgical A Divison of Tyco H | 02/29/2012SE |
| K120268 | Amid StaplerGDW · Special | Safestich Medical, LLC | 02/10/2012SE |
| K112056 | Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic…GDW · Traditional | Ethicon Endo-Surgery, LLC | 12/19/2011SE |
| K111825 | Endo Gia(Tm) Staplers, DST Series(Tm) Gia(Tm) Staplers, DST Series(Tm) Ta(Tm) StaplersGDW · Traditional | Covidien, Formerly US Surgical A Divison of Tyco H | 10/25/2011SE |
| K111195 | Valutrus Reusable Circular Stapler and Disposable ReloadsGDW · Traditional | Ethicon Endo-Surgery, Inc. | 08/03/2011SE |
| K111111 | Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic…GDW · Traditional | Ethicon Endo-Surgery, LLC | 06/08/2011SE |
| K110728 | Imesh TackerGDW · Traditional | Easylap , Ltd. | 06/08/2011SE |
| K111153 | Sorbafix (TM) Absorbable Fixation System, Permafix (TM) Fixation SystemGDW · Special | C.R. Bard, Inc. | 05/24/2011SE |
| K111064 | Tigerpaw System IIGDW · Special | Laax, Inc. | 05/18/2011SE |
| K103672 | Reusable PPH Circular Stapler Handle, PPH Circular Stapler Reload & Accessory SetGDW · Traditional | Ethicon Endo-Surgery, LLC | 04/08/2011SE |
| K110385 | Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterGDW · Traditional | Ethicon Endo-Surgery, Inc. | 03/25/2011SE |
| K110049 | Reusable Linear Stapler HandleGDW · Traditional | Ethicon Endo-Surgery, LLC | 02/10/2011SE |
| K103470 | Panther Group of Surgical Includes: Oanther Circular Stapler; Panther Hemorrhoidal…GDW · Traditional | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 01/11/2011SE |
| K103263 | Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyGDW · Special | Covidien, Formerly US Surgical A Divison of Tyco H | 11/22/2010SE |
| K101961 | Tigerpaw SystemGDW · Traditional | Laax, Inc. | 10/29/2010SE |
| K102325 | Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)GDW · Traditional | Covidien, LLC, Formerly Registered AS Tyco… | 10/13/2010SE |
| K102632 | Ethicon Endo-Surgery 5MM Laparoscopic Multi-Feed StaplerGDW · Traditional | Ethicon Endo-Surgery, Inc. | 10/07/2010SE |
| K102291 | Covidien Endo Gia Radial Reload with Tri-Staple TechnologyGDW · Traditional | Covidien | 09/15/2010SE |
| K101378 | Frankenman Surgical StaplersGDW · Traditional | Suzhou Frankenman Medical Equipment Co., Ltd. | 06/29/2010SE |
| K101444 | Autosuture Endo Gia Single Use Tan Reload with Tri-Staple TechnologyGDW · Special | Surgical Devices, A Global Business Unit Tyco | 06/14/2010SE |
| K100723 | Disposable Circular Stapler, Disposable Circular Stapler Model KYGW-25.5, KYGW-28.5GDW · Traditional | Changzhou Kangdi Medical Stapler Co., Ltd. | 04/30/2010SE |
| K093845 | Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25GDW · Traditional | ETHICON, Inc. | 04/07/2010SE |
| K100386 | Disposable Circular Stapler, Models WHY-25, WHY-29. Why 32GDW · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 03/01/2010SE |
| K092483 | Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018GDW · Traditional | C.R. Bard, Inc. | 12/18/2009SE |
| K093410 | Autosuture Endo Gia Single Use Black Reload with Tri-Staple TechnologyGDW · Special | Surgical Devices, A Divsion of Tyco Healthcare | 11/12/2009SE |
| K093402 | Autosuture Eea OrvilGDW · Special | Surgical Devices, A Global Business Unit Tyco | 11/12/2009SE |
| K093253 | Amid StaplerGDW · Traditional | Safestitch, LLC | 11/12/2009SE |
| K092577 | Ethicon Endo-Surgery Linear Cutter 55MM (NTLC55),SELECTABLE Cartridge 55 / 75MM…GDW · Traditional | Ethicon Endo-Surgery, LLC | 09/15/2009SE |
| K091900 | Absorbatack 5MM Single Use Absorbable Fixation DeviceGDW · Special | Covidien Lp, Formerly Registered AS United States | 07/16/2009SE |
| K090821 | Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…GDW · Traditional | Frankenman International Limited | 06/10/2009SE |
| K091322 | Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40GGDW · Traditional | Ethicon Endo-Surgery, Inc. | 06/01/2009SE |
| K091215 | Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent…GDW · Special | Power Medical Interventions, Inc. | 05/18/2009SE |
| K083519 | Autosuture Endo Gia Staplers with Endo Gia Single Use Loading UnitsGDW · Traditional | Covidien Lp, Formerly Registered AS United States | 04/10/2009SE |
| K090159 | Insorb Absorbable Staple, Model 1020, 1025, and Other Product FamiliesGDW · Special | Incisive Surgical, Inc. | 02/06/2009SE |
| K083781 | Eea Hemorrhoid Stapler & AccessoriesGDW · Traditional | Surgical Devices, A Global Business Unit Covidien | 02/04/2009SE |
| K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086…GDW · Traditional | C.R. Bard, Inc. | 01/02/2009SE |
| K083527 | Intelligent Articulating Endoscopic Linear Cutter Reverse with ReloadsGDW · Special | Power Medical Interventions, Inc. | 12/18/2008SE |
| K071023 | Reach RCS Circular Stapler, Model RCS21C, RCS25C, RCS28C, RCS31C, RCS34CGDW · Traditional | Reach Surgical, Inc. | 08/28/2008SE |
| K081826 | Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads…GDW · Special | Power Medical Interventions, Inc. | 07/25/2008SE |
| K080972 | Echelon Zebra Cartridges, Models, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GPGDW · Traditional | Ethicon Endo-Sugery, LLC | 07/03/2008SE |
| K081146 | Echelon Endoscopic Linear Cutters (Articulating and Straight)GDW · Traditional | Ethicon Endo-Surgery, LLC | 06/26/2008SE |
| K080839 | Echelon Gray Cartridge, Model ERC45MGDW · Traditional | Ethicon Endo-Surgery, LLC | 05/21/2008SE |
| K080898 | Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…GDW · Traditional | Tyco Healthcare Group LP | 05/05/2008SE |
| K073001 | Idrives, Idrivec, IdrivefGDW · Special | Power Medical Interventions, Inc. | 12/18/2007SE |
| K073148 | Idrives, Idrivec, Idrivef with Vascular IndicationsGDW · Special | Power Medical Interventions, Inc. | 12/07/2007SE |
| K071920 | Autosuture Absorbable Tack and ApplicatorGDW · Traditional | United States Surgical, A Division of Tyco Healthc | 09/28/2007SE |
| K071708 | I45, I45S, I60, and I60SGDW · Traditional | Power Medical Interventions, Inc. | 09/27/2007SE |
| K070887 | Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/25/2007SE |
| K071061 | Absorbatack and ApplicatorGDW · Traditional | Sorbx, LLC | 05/16/2007SE |
| K062869 | Contour Curved Cutter Stapler and Reloads, Models CS40B, CS40G, CR40B and CR40GGDW · Traditional | Ethicon Endo-Surgery, LLC | 02/26/2007SE |
| K063746 | Power Extenders Model# PEC200, PES200,PES200SGDW · Special | Power Medical Interventions, Inc. | 01/12/2007SE |
| K063075 | Natural Orifice Linear Cutter Digital Loading UnitsGDW · Special | Power Medical Interventions, Inc. | 11/02/2006SE |
| K062850 | Autosuture Circular Eea Surgical StaplersGDW · Special | United States Surgical, A Division of Tyco Healthc | 10/23/2006SE |
| K061649 | Power Circular Stapler Digital Loading Unit with and Without SheathGDW · Special | Power Medical Interventions, Inc. | 09/01/2006SE |
| K061784 | Insorb Absorbable Staple, Model 1020GDW · Special | Incisive Surgical, Inc. | 07/26/2006SE |
| K061156 | Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60 and…GDW · Traditional | Ethicon Endo-Surgery, Inc. | 07/03/2006SE |
| K060494 | Easytac Anchor. Easytac Delivery SystemGDW · Traditional | Medchannel, LLC | 07/03/2006SE |
| K061095 | Auto Sutur Endo Gia StaplersGDW · Traditional | United States Surgical, A Division of Tyco Healthc | 05/31/2006SE |
| K053631 | Contour Transtar Curved Cutter Stapler SetGDW · Traditional | Ethicon Endo-Surgery, Inc. | 01/30/2006SE |
| K052910 | Power Right Angle Linear Cutter Digital Loading Unit with ReloadsGDW · Special | Power Medical Interventions, Inc. | 11/07/2005SE |
| K052415 | Power Linear Cutter Reusable Digital Loading Units with ReloadsGDW · Special | Power Medical Interventions, Inc. | 09/29/2005SE |
| K051301 | Proximate PPH Hemorrhoidal Circular Stapler and AccessoriesGDW · Traditional | Ethicon Endo-Surgery, Inc. | 08/30/2005SE |
| K051848 | Salute II Disposable Fixation Device, Models 0113070, 0113072, 0113073, 0113077, 0113079GDW · Traditional | Davol Inc., Sub. C. R. Bard, Inc. | 08/11/2005SE |
| K050610 | Salute Fixation SystemGDW · Traditional | Davol Inc., Sub. C. R. Bard, Inc. | 05/25/2005SE |
| K051002 | Endopath Endocutter 60 Endoscopic Linear CutterGDW · Traditional | Ethicon Endo-Surgery, Inc. | 05/17/2005SE |
| K042492 | Hand STC, Model 60MMGDW · Traditional | Niti Medical Technologies , Ltd. | 10/19/2004SE |
| K041159 | JMS Absorbable Anchor and ApplicatorGDW · Traditional | Jms, Inc. | 07/27/2004SE |
| K041331 | Biopsy Sciences, LLC, Lung Biopsy Site MarkerGDW · Traditional | Biopsy Sciences, LLC | 06/15/2004SE |
| K041201 | Ultraclip II MRGDW · Special | Inrad | 06/03/2004SE |
| K040720 | Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMGDW · Traditional | Power Medical Interventions, Inc. | 06/03/2004SE |
| K040109 | Hemorrhage Occluder PinGDW · Traditional | Tools For Surgery, LLC | 03/25/2004SE |
| K040398 | Surgassist Straight Linear 4 Row No Knife Dlus with ReloadsGDW · Traditional | Power Medical Interventions, Inc. | 03/24/2004SE |
| K040038 | Curved Cutter Stapler, Models CS40B, CS40G; Reload for Curved Stapler, Models CR40B, CR40GGDW · Traditional | Ethicon Endo-Surgery, Inc. | 02/04/2004SE |
| K040024 | Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29GDW · Special | Power Medical Interventions, Inc. | 02/04/2004SE |
| K032973 | Reprocessed Disposable Cutters, Staplers and AppliersGDW · Traditional | Vanguard Medical Concepts, Inc. | 12/18/2003SE |
| K033602 | Insorb Absorbable Staple, Model SP-B20GDW · Special | Incisive Surgical, Inc. | 12/16/2003SE |
| K032696 | Auto Suture Endoscopic (& Open) Ta Surgical Stapler, Auto Suture Endoscopic (& Open) Gia…GDW · Traditional | United States Surgical, A Division of Tyco Healthc | 12/01/2003SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0486-2026 Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX…A manufacturing issue could lead to a malformed cover tube press which can lead to internal components'… | Covidien, LP | 09/25/2025Open, Classified |
| Z-0485-2026 Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN:…A manufacturing issue could lead to a malformed cover tube press which can lead to internal components'… | Covidien, LP | 09/25/2025Open, Classified |
| Z-0147-2026 Class II | ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or…The devices were shipped unsterilized. | Ethicon Endo-Surgery Inc | 09/11/2025Open, Classified |
| Z-1746-2025 Class I | Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product…Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures… | Ethicon Endo-Surgery Inc | 04/22/2025Open, Classified |
| Z-3097-2024 Class II | ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of…Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding… | Smith & Nephew Inc. | 08/12/2024Open, Classified |
| Z-3096-2024 Class II | ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of…Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding… | Smith & Nephew Inc. | 08/12/2024Open, Classified |
| Z-1891-2024 Class II | Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal…Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may… | Covidien, LP | 04/15/2024Open, Classified |
| Z-1458-2024 Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTUnder certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially… | Covidien, LP | 02/14/2024Open, Classified |
| Z-1457-2024 Class II | Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTUnder certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially… | Covidien, LP | 02/14/2024Open, Classified |
| Z-0834-2024 Class II | ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath…There is the potential for incomplete staple line formation during the firing sequence, without most or all… | Ethicon Endo-Surgery Inc | 12/11/2023Open, Classified |
| Z-1228-2023 Class II | Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXTAffected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to… | Covidien, LP | 01/25/2023Open, Classified |
| Z-2326-2021 Class II | ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation…Mislabeled: Labeled on the package as 60mm contains 45mm devices | Ethicon Endo-Surgery Inc | 06/03/2021Terminated |
| Z-1419-2021 Class II | Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with…Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility… | Covidien Llc | 03/23/2021Terminated |
| Z-1383-2021 Class II | Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm -…Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload… | Covidien, LP | 03/04/2021Terminated |
| Z-0748-2021 Class II | Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3.…May contain a damaged internal component which could impede staple deployment and result in incomplete… | Covidien Llc | 11/23/2020Completed |
| Z-0747-2021 Class II | Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended…May contain a damaged internal component which could impede staple deployment and result in incomplete… | Covidien Llc | 11/23/2020Completed |
| Z-0009-2021 Class II | Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | Covidien, LP | 08/12/2020Open, Classified |
| Z-0008-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | Covidien, LP | 08/12/2020Open, Classified |
| Z-0007-2021 Class II | Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | Covidien, LP | 08/12/2020Open, Classified |
| Z-0006-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | Covidien, LP | 08/12/2020Open, Classified |
| Z-0005-2021 Class II | Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | Covidien, LP | 08/12/2020Open, Classified |
| Z-0004-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | Covidien, LP | 08/12/2020Open, Classified |
| Z-0003-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | Covidien, LP | 08/12/2020Open, Classified |
| Z-0002-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | Covidien, LP | 08/12/2020Open, Classified |
| Z-0001-2021 Class II | Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | Covidien, LP | 08/12/2020Open, Classified |
| Z-1264-2020 Class II | Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in…Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result… | Covidien LLC | 01/17/2020Terminated |
| Z-0203-2020 Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60AThe staplers may contain an out of specification anvil component within the jaw of the device. This… | Ethicon Endo-Surgery Inc | 10/03/2019Terminated |
| Z-0202-2020 Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60AThe staplers may contain an out of specification anvil component within the jaw of the device. This… | Ethicon Endo-Surgery Inc | 10/03/2019Terminated |
| Z-0201-2020 Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60AThe staplers may contain an out of specification anvil component within the jaw of the device. This… | Ethicon Endo-Surgery Inc | 10/03/2019Terminated |
| Z-0200-2020 Class I | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60AThe staplers may contain an out of specification anvil component within the jaw of the device. This… | Ethicon Endo-Surgery Inc | 10/03/2019Terminated |
| Z-1836-2019 Class II | SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1835-2019 Class II | SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1834-2019 Class II | SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1833-2019 Class II | SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1832-2019 Class II | SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1831-2019 Class II | EGIA45 CT AR MD THK REL, EGIA45CTAMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1830-2019 Class II | EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1829-2019 Class II | EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1828-2019 Class II | EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1827-2019 Class II | EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1826-2019 Class II | EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1825-2019 Class II | EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMTThe device may be missing one of two pin components that maintain alignment of the device jaws, resulting in… | Covidien LLC | 05/17/2019Open, Classified |
| Z-1278-2019 Class I | Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Ethicon Endo-Surgery Inc | 04/11/2019Completed |
| Z-1277-2019 Class I | Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Ethicon Endo-Surgery Inc | 04/11/2019Completed |
| Z-1276-2019 Class I | Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Ethicon Endo-Surgery Inc | 04/11/2019Completed |
| Z-1275-2019 Class I | Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Ethicon Endo-Surgery Inc | 04/11/2019Completed |
| Z-1274-2019 Class I | Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Ethicon Endo-Surgery Inc | 04/11/2019Completed |
| Z-1273-2019 Class I | Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Ethicon Endo-Surgery Inc | 04/11/2019Completed |
| Z-1272-2019 Class I | Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Ethicon Endo-Surgery Inc | 04/11/2019Completed |
| Z-1271-2019 Class I | Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon…The staplers may have an insufficient firing stroke to break the washer and completely form staples. | Ethicon Endo-Surgery Inc | 04/11/2019Completed |