Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
FDA product code KNS · Class II (moderate risk) · 21 CFR 876.4300 · Gastroenterology, Urology
189510(k) clearances
0PMA approvals
124recalls
Manufacturers
- Boston Scientific Corporation 18
- Wilson-Cook Medical, Inc. 12
- Olympus Medical Systems Corp. 10
- Mr Associates, Inc. 5
- Creo Medical, Ltd. 5
- Aqua Medical, Inc. 5
- Circon Acmi 4
- Everest Medical Corp. 4
- Vidamed, Inc. 4
- Nxthera, Inc. 3
- Gyrus Medical, Inc. 3
- CooperSurgical, Inc. 3
- Biosearch Medical Products, Inc. 3
- Microvasive 3
- Wilson-Cook Medical Inc./Cook Endoscopy 3
- Promedicon, Inc. 3
- Olympus America, Inc. 3
- United States Endoscopy Group, Inc. 3
- Emcision , Ltd. 3
- Olympus Corp. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262460 | Rezum SystemKNS · Traditional | Boston Scientific | 09/03/2026SE |
| K260962 | SphincterotomeKNS · Traditional | Taewoong Medical Co., Ltd. | 05/21/2026SE |
| K252388 | Vanquish Water Vapor Ablation DeviceKNS · Traditional | Francis Medical, Inc. | 11/26/2025SE |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS · Traditional | Olympus Medical Systems Corporation | 11/25/2025SE |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…KNS · Traditional | Olympus Medical Systems Corp. | 10/17/2025SE |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional | Olympus Medical Systems Corporation | 10/10/2025SE |
| K251104 | SureTome SW Sphincterotome with DomeTipKNS · Traditional | Wilson-Cook Medical | 09/29/2025SE |
| K251226 | Aqua Medical RF Vapor Ablation SystemKNS · Traditional | Aqua Medical, Inc. | 08/08/2025SE |
| K250584 | Rezum SystemKNS · Traditional | Boston Scientific Corporation | 06/11/2025SE |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional | Creo Medical, Ltd. | 06/06/2025SE |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L)KNS · Traditional | Sb-Kawasumi Laboratories, Inc. | 03/26/2025SE |
| K242192 | Disposable SphincterotomeKNS · Traditional | Beijing Zksk Technology Co., Ltd. | 02/06/2025SE |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordKNS · Special | Wilson-Cook Medical, Inc. | 01/17/2025SE |
| K241271 | Aqua Medical RF Vapor Ablation SystemKNS · Traditional | Aqua Medical, Inc. | 12/12/2024SE |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002)KNS · Special | Creo Medical, Ltd. | 08/15/2024SE |
| K232825 | Disposable SphincterotomeKNS · Traditional | Jiangsu Vedkang Medical Science and Technology… | 03/29/2024SE |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar…KNS · Traditional | Boston Scientific | 11/28/2023SE |
| K232476 | Disposable SphincterotomeKNS · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 11/07/2023SE |
| K230328 | Speedboat Flush SB1 InstrumentKNS · Traditional | Creo Medical, Ltd. | 10/31/2023SE |
| K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and…KNS · Special | Boston Scientific Corporation | 10/27/2023SE |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)KNS · Special | Starmed Co., Ltd. | 10/25/2023SE |
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44…KNS · Special | Boston Scientific Corporation | 08/14/2023SE |
| K231533 | Habib EndoHPBKNS · Special | Boston Scientific Corporation | 06/21/2023SE |
| K222421 | SphincterotomeKNS · Traditional | Hangzhou AGS MedTech Co., Ltd. | 05/03/2023SE |
| K223256 | Optimos CystotomeKNS · Traditional | Taewoong Medical Co., Ltd. | 04/05/2023SE |
| K222542 | MCB UNIT Model: V10GMCBUSKNS · Traditional | Lamidey Noury Medical | 09/21/2022SE |
| K211909 | Cysto-Gastro-SetsKNS · Traditional | G-Flex Europe Sprl | 06/09/2022SE |
| K212999 | Multi-Functional Electrosurgical KnifeKNS · Traditional | Anrei Medical (Hangzhou) Co., Ltd. | 03/21/2022SE |
| K213627 | RF Vapor SystemKNS · Special | Aqua Medical, Inc. | 12/17/2021SE |
| K210934 | Sphincterotome / short-wire compatible, Sterile SphincterotomeKNS · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 12/01/2021SE |
| K211282 | Aqua Medical RF Vapor SystemKNS · Special | Aqua Medical, Inc. | 05/27/2021SE |
| K201121 | SphincterotomeKNS · Traditional | Hangzhou AGS MedTech Co., Ltd. | 02/05/2021SE |
| K200404 | ORISE ProKnifeKNS · Traditional | Boston Scientific Corporation | 12/03/2020SE |
| K192342 | Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare…KNS · Traditional | Hangzhou AGS MedTech Co., Ltd. | 05/21/2020SE |
| K192905 | Creo Electrosurgical System with HS1 Hemostasis AccessoryKNS · Traditional | Creo Medical, Ltd. | 03/19/2020SESK |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active CordKNS · Traditional | Wilson-Cook Medical, Inc. | 01/30/2020SE |
| K193039 | Single Use Balloon Dilator V (with knife)KNS · Traditional | Olympus Medical Systems Corp. | 12/17/2019SE |
| K191505 | Rezum SystemKNS · Special | Nxthera (A Boston Scientific Company) | 08/02/2019SE |
| K183595 | Aqua Medical RF Vapor SystemKNS · Traditional | Aqua Medical, Inc. | 06/21/2019SE |
| K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645KNS · Traditional | Olympus Medical Systems Corp. | 05/15/2019SE |
| K190621 | SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - LongKNS · Traditional | Sumitomo Bakelite Co., Ltd. | 04/23/2019SE |
| K181758 | ELRA ElectrodeKNS · Traditional | Starmed Co., Ltd. | 04/11/2019SE |
| K190093 | Rezum Delivery Device, Rezum GeneratorKNS · Special | Nxthera (A Boston Scientific Company) | 03/25/2019SE |
| K172665 | Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton…KNS · Traditional | Wilson-Cook Medical Inc./Cook Endoscopy | 05/24/2018SE |
| K172288 | Fusion OMNI SphincterotomeKNS · Traditional | Wilson-Cook Medical Inc./Cook Endoscopy | 04/17/2018SE |
| K180165 | Habib EndoHPBKNS · Traditional | Emcision , Ltd. | 03/20/2018SE |
| K180237 | Rezum SystemKNS · Special | Nxthera, Inc. | 02/27/2018SE |
| K173559 | Barrx SB RFA Endoscopic CatheterKNS · Special | Covidien, LLC | 01/18/2018SE |
| K171158 | Single Use Electrosurgical knifeKNS · Traditional | Olympus Medical Systems Corp. | 11/17/2017SE |
| K171993 | Zimmon Needle Knife PapillotomeKNS · Traditional | Wilson-Cook Medical Inc./Cook Endoscopy | 08/17/2017SE |
| K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryKNS · Traditional | Creo Medical, Ltd. | 08/17/2017SE |
| K152771 | SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - LongKNS · Traditional | Sumitomo Bakelite Co., Ltd. | 06/17/2016SE |
| K160417 | Rezum SystemKNS · Special | Nxthera, Inc. | 03/17/2016SE |
| K160241 | Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215KNS · Special | Olympus Medical Systems Corp. | 03/02/2016SE |
| K150142 | Single Use Balloon Dilator V (with Knife)KNS · Traditional | Olympus Medical Systems Corp. | 10/08/2015SE |
| K150786 | Rezum SystemKNS · Traditional | Nxthera, Inc. | 08/27/2015SE |
| K141991 | Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SPKNS · Traditional | Olympus Medical Systems Copr. | 03/31/2015SE |
| K133933 | Injection Gold Probe Bipolar Electrohemostasis CatheterKNS · Special | Boston Scientific Corporation | 04/02/2014SE |
| K130623 | Barrx Channel Rfa Endoscopic CatheterKNS · Traditional | Covidien, LLC | 07/26/2013SE |
| K122505 | Single Use Preloaded Sphincterotome VKNS · Traditional | Olympus Medical Systems Corp. | 04/11/2013SE |
| K123319 | Gyrus Acmi Bicoag Hemostasis ProbeKNS · Special | Olympus Surgical Technologies America | 12/14/2012SE |
| K122203 | TruetomeKNS · Special | Boston Scientific Corp | 08/17/2012SE |
| K110887 | Injection Gold Probe Bipolar Electrohemostasis CatheterKNS · Special | Boston Scientific Corporation | 04/14/2011SE |
| K092571 | Gyrus Acmi Biocoag ProbeKNS · Traditional | Gyrus Acmi, Inc. | 10/20/2010SE |
| K102273 | Merit Bipolar Coagulation ProbeKNS · Special | Merit Medical Systems, Inc. | 09/07/2010SE |
| K093079 | Touchsoft Coagulator with Banana Fitting, Model 4581 and with Universal Fitting, Model…KNS · Traditional | Hobbs Medical, Inc. | 08/02/2010SE |
| K101139 | Prostiva RF Therapy Model 8929 Hand PieceKNS · Special | Medtronic, Inc. | 05/21/2010SE |
| K092309 | Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L…KNS · Traditional | Olympus Medical Systems Corporation | 10/30/2009SE |
| K083292 | Habib EndohpbKNS · Traditional | Emcision , Ltd. | 06/10/2009SE |
| K083275 | Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable Maxi-Guide…KNS · Traditional | Max Endoscopy, Inc. | 06/09/2009SE |
| K082114 | Electrocautery Dilation Balloon, Models: EDB-0018-00, EDB-0020-00, EDB-0022-00KNS · Traditional | Apollo Endosurgery, Inc. | 12/19/2008SE |
| K082464 | Prostiva RF Therapy Hand Piece, Model 8929KNS · Traditional | Medtronic, Inc. | 10/27/2008SE |
| K080946 | Conmed Axcess Papillotome Models AX4535, AX4535FXKNS · Traditional | Conmed Endoscopic Technologies, Inc. | 05/20/2008SE |
| K072383 | Habib EndoblateKNS · Traditional | Emcision , Ltd. | 11/29/2007SE |
| K061684 | Medi-Globe Rota-Cut SphincterotomeKNS · Traditional | Medi-Globe Corporation | 06/27/2006SE |
| K052413 | Tuna System, Models 8909, 8929, 8930, 8934KNS · Traditional | Medtronic Vascular | 11/17/2005SE |
| K052051 | Omni SphincterotomeKNS · Special | Wilson-Cook Medical, Inc. | 08/05/2005SE |
| K050578 | Cook Ireland Duette Multi-Band Mucosectomy DeviceKNS · Traditional | Cook Ireland, Ltd. | 04/22/2005SE |
| K033135 | Stryker Wireless Universal Footswitch SystemKNS · Traditional | Stryker Endoscopy | 08/09/2004SE |
| K040981 | Usw Needleknife PapillotomeKNS · Special | Wilson-Cook Medical, Inc. | 05/07/2004SE |
| K033203 | Wilson-Cook Tri-Tome Select PlusKNS · Traditional | Wilson-Cook Medical, Inc. | 12/19/2003SE |
| K031026 | Eti Bipolar Hemostatic ProbeKNS · Traditional | Endo-Therapeutics, Inc. | 06/27/2003SE |
| K030194 | XUES-41 Endoscopic Electrosurgical UnitKNS · Traditional | The Olympus Optical Co. | 03/24/2003SE |
| K030315 | Modification to Ultroid Hemorrhoid Management SystemKNS · Special | Ultroid, LLC | 02/27/2003SE |
| K023706 | Ultroid Hemorrhoid Management SystemKNS · Traditional | Ultroid, LLC | 01/14/2003SE |
| K022595 | Wilson-Cook CystotomeKNS · Traditional | Wilson-Cook Medical, Inc. | 10/17/2002SE |
| K021266 | Endo Window High Frequency Electrocautery Device, Model EW018KNS · Traditional | Ethicon Endo-Surgery, Inc. | 09/27/2002SE |
| K012587 | RF Generators, Disposable Cartridge Kit, Disposable Cartridge, Reusable Handle…KNS · Traditional | Vidamed, Inc. | 12/11/2001SE |
| K013153 | Autotome RX Model # 4515, 4516KNS · Special | Boston Scientific Corp | 10/19/2001SE |
| K011787 | Precision Tuna Office System with No Rectal Temperature Monitoring TapeKNS · Special | Vidamed, Inc. | 07/06/2001SE |
| K010568 | Arthrocare Urology Electrosurgery SystemKNS · Special | Arthrocare Corp. | 03/27/2001SE |
| K002583 | Tuna (Trans Urethra Needle) Office SystemKNS · Traditional | Vidamed, Inc. | 02/13/2001SE |
| K002236 | Horizons PapillotomeKNS · Traditional | Horizons Intl. Corp. | 01/23/2001SE |
| K003569 | Plasmakinetic Endourology SystemKNS · Special | Gyrus Medical , Ltd. | 12/19/2000SE |
| K002802 | Rapid Exchange TapertomeKNS · Special | Boston Scientific Corp | 10/05/2000SE |
| K000508 | Thermoflex SystemKNS · Traditional | Argomed, Inc. | 04/18/2000SE |
| K994166 | Gyrus Endourology System: Axipolar Resectoscope ElectrodeKNS · Special | Gyrus Medical , Ltd. | 12/27/1999SE |
| K992402 | 5.0 French X 200CM X 35MM Tip TAPER-20MM Cutting Wire, 5.0 French X 200CM X 35MM Tip…KNS · Traditional | Telemed Systems, Inc. | 12/22/1999SE |
| K991847 | Thermoflex SystemKNS · Traditional | Argomed, Inc. | 08/26/1999SE |
| K990628 | Gyrus Endourology SystemKNS · Traditional | Gyrus Medical , Ltd. | 06/29/1999SE |
| K990852 | Coopersurgical Infrared CoagulatorKNS · Traditional | CooperSurgical, Inc. | 06/11/1999SE |
| K990850 | Coopersurgical Coagulator for Tattoo RemovalKNS · Traditional | CooperSurgical, Inc. | 06/01/1999SE |
| K990376 | Ballard Medical Products Faciletome Bow String PapillotomeKNS · Traditional | Ballard Medical Products | 05/03/1999SE |
| K990855 | Coopersurgical Infrared Coagulator for ENTKNS · Traditional | CooperSurgical, Inc. | 03/30/1999SE |
| K990145 | Wilson-Cook Bipolar ProbeKNS · Traditional | Wilson-Cook Medical, Inc. | 03/25/1999SE |
| K982557 | Bard Proforma and Apollo Pre-Curved PapillotomesKNS · Traditional | Bard Interventional Products Div. | 09/10/1998SE |
| K982289 | Heat Probe Unit HPU-20, Heat Probe CD-110##/120##KNS · Traditional | Olympus America, Inc. | 08/19/1998SE |
| K974168 | Coopersurgical Infrared CoagulatorKNS · Traditional | Hogan & Hartson | 01/23/1998SE |
| K973826 | SphincterotomeKNS · Traditional | Boston Scientific Corp | 12/05/1997SE |
| K973366 | Cobra Hand PieceKNS · Traditional | Vidamed, Inc. | 11/26/1997SE |
| K972674 | Wilson-Cook Needle Knife PapillotomeKNS · Traditional | Wilson-Cook Medical, Inc. | 08/15/1997SE |
| K970945 | Angled Tip Polypectomy SnareKNS · Traditional | United States Endoscopy Group, Inc. | 05/07/1997SE |
| K970278 | Microvasive Gold ProbeKNS · Traditional | Boston Scientific Corp | 04/11/1997SE |
| K970053 | UltratomerxKNS · Traditional | Boston Scientific Corp | 03/28/1997SE |
| K963484 | Bard High Flow PapillotomeKNS · Traditional | Bard Interventional Products Div. | 11/19/1996SE |
| K962083 | Karl Storz Remorgida ForcepsKNS · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/01/1996SE |
| K962346 | PapillotomeKNS · Traditional | United States Endoscopy Group, Inc. | 08/08/1996SE |
| K960231 | SphincterotomeKNS · Traditional | Lighthouse Medical, Inc. | 07/31/1996SE |
| K961762 | Reusable Endoscopic Accessory HandleKNS · Traditional | United States Endoscopy Group, Inc. | 07/22/1996SE |
| K961349 | Injection Gold ProbeKNS · Traditional | Boston Scientific Corp | 05/15/1996SE |
| K955247 | Olympus KD Series SphincterotomeKNS · Traditional | Olympus America, Inc. | 04/30/1996SE |
| K946109 | Cabot Medical Reusable Bipolar Cutting ForcepsKNS · Traditional | Cabot Medical Corp. | 11/21/1995SE |
| K943629 | Gip/Medi-Globe PapillotomeKNS · Traditional | Medi-Globe Corp. | 05/26/1995SE |
| K950836 | Redfield Infrared CoagulatorKNS · Traditional | Hogan & Hartson | 03/24/1995SE |
| K950166 | Olympus KD-6G1-9Q Wire Guided Papillotomu KnifeKNS · Traditional | Olympus America, Inc. | 02/22/1995SE |
| K945764 | High Temperature Cautery Elongated Fine TipKNS · Traditional | Aaron Medical Industries | 01/30/1995SE |
| K944955 | Aesculap Thoracoscopic InstrumentsKNS · Traditional | Aesculap, Inc. | 11/09/1994SE |
| K942301 | Microvasive Injection Gold ProbeKNS · Traditional | Boston Scientific Corp | 11/02/1994SE |
| K932293 | Cabot Medical Bipolar Cutting ForcepsKNS · Traditional | Cabot Medical Corp. | 07/27/1994SE |
| K941728 | Monopolar Coagulating Polypectomy SnareKNS · Traditional | Endoscopic Innovations, Inc. | 06/27/1994SE |
| K942068 | American Catheter SphincterotomeKNS · Traditional | Intl. Medical, Inc. | 06/24/1994SE |
| K934315 | Endovations(R) .035 Pre-Cut PapillatomeKNS · Traditional | Endovations | 02/28/1994SE |
| K921029 | Dobbhoff Bipolar AdapterKNS · Traditional | Biosearch Medical Products, Inc. | 05/06/1992SE |
| K920089 | Monopolar Coagulating Polypectomy SnareKNS · Traditional | Everest Medical Corp. | 03/31/1992SE |
| K915408 | Bipolar Endostasis Probe, Best (TM)KNS · Traditional | Medical Devices, Inc. | 03/11/1992SE |
| K913881 | Endostat Electrosurgical UnitKNS · Traditional | Medical and Scientific Enterprises, Inc. | 11/01/1991SE |
| K912129 | Dobbhoff(R) Bipolar Hemostatic ProbeKNS · Traditional | Biosearch Medical Products, Inc. | 08/07/1991SE |
| K911648 | Redfield Infrared CoagulatorKNS · Traditional | Redfield Corp. | 07/11/1991SE |
| K911600 | Ilco Infrared Light CoagulatorKNS · Traditional | Holl Meditronics, Inc. | 07/09/1991SE |
| K911700 | Monopolar Pollypectomy SnareKNS · Traditional | Everest Medical Corp. | 07/01/1991SE |
| K912601 | Biprobe(Tm)KNS · Traditional | C.R. Bard, Inc. | 06/20/1991SE |
| K903323 | Resectoscope LoopsKNS · Traditional | Olympus Corp. | 10/01/1990SE |
| K901443 | Zimmon PapillotomeKNS · Traditional | Wilson-Cook Medical, Inc. | 06/18/1990SE |
| K896612 | Dobbhoff(R) PapillotomeKNS · Traditional | Biosearch Medical Products, Inc. | 02/12/1990SE |
| K896507 | Porges Diathermy SnareKNS · Traditional | Porges Corp. | 01/29/1990SE |
| K896426 | Porges SphincterotomesKNS · Traditional | Porges Corp. | 01/22/1990SE |
| K895855 | PhoenixKNS · Traditional | Medical and Scientific Enterprises, Inc. | 01/22/1990SE |
| K895842 | Bitome(Tm) Bipolar SphincterotomeKNS · Traditional | Everest Medical Corp. | 01/11/1990SE |
| K894861 | Wiltek PapillotomeKNS · Traditional | Wiltek Medical, Inc. | 12/21/1989SE |
| K892895 | Model 8800 Bipolar Coagulation Therapeutic SystemKNS · Traditional | Everest Medical Corp. | 09/25/1989SE |
| K884025 | Circon Acmi Bicap II Therapeutic System BC-200KNS · Traditional | Circon Acmi | 03/03/1989SE |
| K885005 | Microvasive Gold ProbeKNS · Traditional | Boston Scientific Corp | 02/01/1989SE |
| K884254 | Circon Acmi Bicap III Therapeutic SystemKNS · Traditional | Circon Acmi | 01/11/1989SE |
| K884252 | Circon Acmi Bicap Hemorrhoid System BH-10 & BHP-20KNS · Traditional | Circon Acmi | 01/10/1989SE |
| K884306 | Bicap Ablating Forceps BAF-7KNS · Traditional | Circon Acmi | 01/05/1989SE |
| K882048 | Meditron Endolav Model EL-100KNS · Traditional | Xylog Corp. | 10/31/1988SE |
| K880748 | Ball Tip Fulgurating Electrode, 3 FrenchKNS · Traditional | Cook Urological, Inc. | 08/04/1988SE |
| K870705 | Thermal CoagulatorKNS · Traditional | Microvasive | 04/17/1987SE |
| K864413 | Model HSE-5M Microwave Surgery Equipment/MicrotazeKNS · Traditional | Cooper Lasersonics, Inc. | 12/09/1986SE |
| K861904 | HS-15M Microwave Surgery Equipment, MicrotazeKNS · Traditional | Cooper Lasersonics, Inc. | 10/16/1986SE |
| K860593 | Et/Rt PapillotomeKNS · Traditional | Hobbs Medical, Inc. | 07/22/1986SE |
| K862060 | Polypectomy SnareKNS · Traditional | Endovations | 06/27/1986SE |
| K860366 | Challenger Hot Biopsy ForcepsKNS · Traditional | Microvasive | 04/07/1986SE |
| K853680 | Endodynamic Siegel SphincterotomeKNS · Traditional | E-Z-Em, Inc. | 11/04/1985SE |
| K851958 | Rotatable Polypectomy Snare POS-1KNS · Traditional | Wilson-Cook Medical, Inc. | 07/25/1985SE |
| K851652 | PapillotomeKNS · Traditional | Microvasive | 06/24/1985SE |
| K851964 | E.R.C.P.-1 Endoscopic Retrograde Cholangio-CatheteKNS · Traditional | Wilson-Cook Medical, Inc. | 06/13/1985SE |
| K851096 | Hpu Heat Probe Automated Electrocautery SystemKNS · Traditional | Olympus Corp. | 05/22/1985SE |
| K845015 | Davol PapillitomeKNS · Traditional | C.R. Bard, Inc. | 01/15/1985SE |
| K842810 | Infrared CoagulatorKNS · Traditional | Endo Lase, Inc. | 10/18/1984SE |
| K820430 | Diathermic SnaresKNS · Traditional | American Endoscopy, Inc. | 04/08/1982SE |
| K820240 | PapillotomesKNS · Traditional | American Endoscopy, Inc. | 03/26/1982SE |
| K820405 | Ground Aid CaphesiveKNS · Traditional | Promedicon, Inc. | 03/02/1982SE |
| K820196 | Electrosurgical Disp. Dispersive PadKNS · Traditional | Promedicon, Inc. | 02/12/1982SE |
| K813434 | Electrosurgical Disp. Dispersive PadKNS · Traditional | Promedicon, Inc. | 01/12/1982SE |
| K812213 | Automated Electrocautery SystemKNS · Traditional | University of Washington | 11/05/1981SE |
| K810336 | Polypectomy SnareKNS · Traditional | Medi-Tech, Inc. | 03/20/1981SE |
| K802444 | Papillotome ProductKNS · Traditional | Mill-Rose Laboratory | 10/23/1980SE |
| K800915 | Johnloz Endoscopy HandleKNS · Traditional | Endoscopic Surgical Accessories, Inc. | 05/30/1980SE |
| K800975 | M.R. Assoc. True-Feel HandleKNS · Traditional | Mr Associates, Inc. | 05/08/1980SE |
| K800974 | M.R. Assoc. Power CordKNS · Traditional | Mr Associates, Inc. | 05/08/1980SE |
| K800973 | M.R. Assoc. Hot Biopsy ForcepsKNS · Traditional | Mr Associates, Inc. | 05/08/1980SE |
| K800965 | M.R. Assoc. Snares; Crescent Snare WireKNS · Traditional | Mr Associates, Inc. | 05/08/1980SE |
| K800964 | M.R. Assoc. Ball Type CoagulatorKNS · Traditional | Mr Associates, Inc. | 05/08/1980SE |
| K800321 | Concept Suction CoagulatorKNS · Traditional | Concept, Inc. | 02/28/1980SE |
| K781353 | Papillotome Cutting SnareKNS · Traditional | Cameron-Miller, Inc. | 10/10/1978SE |
| K780774 | Papillotomy KnivesKNS · Traditional | Olympus Corp. | 07/27/1978SE |
| K770280 | Cord, Electrosurgical-Sterile & Dispos.KNS · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 04/15/1977SE |
| K760178 | Electrode, Cutting LoopKNS · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 10/15/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3247-2026 | Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | Olympus Corporation of the Americas | 08/19/2026Open, Classified |
| Z-3246-2026 | Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | Olympus Corporation of the Americas | 08/19/2026Open, Classified |
| Z-3245-2026 | Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | Olympus Corporation of the Americas | 08/19/2026Open, Classified |
| Z-3244-2026 | Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | Olympus Corporation of the Americas | 08/19/2026Open, Classified |
| Z-1297-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1296-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1295-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1294-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1293-2026 Class II | Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1292-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1291-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1290-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1289-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1288-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1287-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1286-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1285-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1284-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1283-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1282-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1281-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1280-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1279-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1278-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1277-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1276-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1275-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1274-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1273-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1272-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1271-2026 Class II | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1270-2026 Class II | Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1269-2026 Class II | Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number:…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1268-2026 Class II | Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog…Devices which did not undergo thermoforming could deform and lose performance. | Olympus Corporation of the Americas | 01/07/2026Open, Classified |
| Z-1163-2026 Class I | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1162-2026 Class I | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1161-2026 Class I | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1160-2026 Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1159-2026 Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1158-2026 Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1362-2026 Class II | Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code:…Due to product that may contain a void in the material that separates the wire guide and cutting wire… | Wilson-Cook Medical Inc. | 12/18/2025Open, Classified |
| Z-1037-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | Boston Scientific Corporation | 12/20/2024Open, Classified |
| Z-1036-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | Boston Scientific Corporation | 12/20/2024Open, Classified |
| Z-1035-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | Boston Scientific Corporation | 12/20/2024Open, Classified |
| Z-1034-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | Boston Scientific Corporation | 12/20/2024Open, Classified |
| Z-1033-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | Boston Scientific Corporation | 12/20/2024Open, Classified |
| Z-1032-2025 Class II | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | Boston Scientific Corporation | 12/20/2024Open, Classified |
| Z-1031-2025 Class II | AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | Boston Scientific Corporation | 12/20/2024Open, Classified |
| Z-1030-2025 Class II | AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | Boston Scientific Corporation | 12/20/2024Open, Classified |
| Z-1029-2025 Class II | AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle… | Boston Scientific Corporation | 12/20/2024Open, Classified |