Laparoscope, General & Plastic Surgery
FDA product code GCJ · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
1,430510(k) clearances
0PMA approvals
255recalls
Manufacturers
- KARL STORZ Endoscopy-America, Inc. 51
- Origin Medsystems, Inc. 34
- Phx Technologies Corp. 33
- Ethicon Endo-Surgery, Inc. 31
- United States Surgical, A Division of Tyco Healthc 30
- Richard Wolf Medical Instruments Corp. 28
- Applied Medical Resources Corp 26
- Stryker Endoscopy 25
- Computer Motion, Inc. 21
- Stryker Corporation 20
- The Tulip Mfg. Co. 19
- Advanced Surgical, Inc. 18
- ETHICON, Inc. 18
- Intuitive Surgical, Inc. 17
- Smith & Nephew, Inc. 15
- Aesculap, Inc. 14
- Sopro 13
- Covidien LLC 13
- Core Dynamics, Inc. 12
- Dexide, Inc. 11
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262397 | CuratOR EX2742GCJ · Traditional | Eizo Corporation | 09/11/2026SE |
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorGCJ · Traditional | Sony Corporation | 08/26/2026SE |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)GCJ · Traditional | Freyja Healthcare, LLC | 08/13/2026SE |
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
| K252532 | Inno-Port Disposable Bladed TrocarGCJ · Traditional | Taiwan Surgical Corporation | 06/02/2026SE |
| K260318 | 4K NIR/ICG Imaging SystemGCJ · Traditional | Zhejiang Healnoc Technology Co., Ltd. | 05/26/2026SE |
| K260183 | MediBot Needle Driver UnoGCJ · Traditional | Parallel Robotics, LLC | 05/24/2026SE |
| K252985 | LaportGCJ · Traditional | Sejong Medical Co., Ltd. | 05/19/2026SE |
| K254228 | KARL STORZ Trocars with Valve SealsGCJ · Traditional | Karl Storz SE & CO. KG | 05/11/2026SE |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)GCJ · Traditional | Kms Medical Technology Co., Ltd. | 04/30/2026SE |
| K260197 | Shogun Axis Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)GCJ · Traditional | Suzhou Shenyun Medical Equipment Co., Ltd. | 04/08/2026SE |
| K260089 | TL-10 Laparoscopic Scope CleanerGCJ · Traditional | Scopix , Ltd. | 04/08/2026SE |
| K252714 | C-Lant PortGCJ · Traditional | Vigor Medical Technologies , Ltd. | 02/27/2026SE |
| K253978 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 02/24/2026SE |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…GCJ · Special | Stryker Endoscopy | 02/18/2026SE |
| K260177 | Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)GCJ · Special | Xenocor, Inc. | 02/12/2026SE |
| K251923 | Medical Shaver System (Morcellator) (YSB-IIIA)GCJ · Traditional | Hangzhou Hawk Optical Electronic Instruments… | 01/29/2026SE |
| K252957 | Pneumo Dissector HookGCJ · Traditional | Ab Medica Sas | 01/23/2026SE |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with…GCJ · Special | Stryker Endoscopy | 01/13/2026SE |
| K250927 | KARL STORZ Cholangiography SetGCJ · Traditional | Karl Storz SE & CO. KG | 11/22/2025SE |
| K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K)GCJ · Traditional | Integrated Endoscopy, Inc. | 11/20/2025SE |
| K252442 | Kii Structural Balloon Access SystemGCJ · Traditional | Applied Medical Resources Corp. | 10/31/2025SE |
| K252697 | 3D LaparoscopeGCJ · Traditional | Guangdong Optomedic Technologies, Inc. | 10/29/2025SE |
| K252640 | VereSee Optical Veres Needle and Endoscopic CameraGCJ · Traditional | Freyja Healthcare, LLC | 10/20/2025SE |
| K251994 | Arthrex Synergy Vision Imaging SystemGCJ · Traditional | Arthrex, Inc. | 10/16/2025SE |
| K243968 | Revolve Surgical SystemGCJ · Traditional | Revolve Surgical, Inc. | 10/03/2025SE |
| K250551 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)GCJ · Traditional | Shenzhen Sophway Technology Co., Ltd. | 10/02/2025SE |
| K251743 | SPI LaproSac Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval SystemGCJ · Traditional | Surgical Principals, Inc. | 09/22/2025SE |
| K250130 | Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532…GCJ · Traditional | Hangzhou Viction Medical Technology Co.,Ltd | 08/06/2025SE |
| K250124 | Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532…GCJ · Traditional | Hangzhou Viction Medical Technology Co.,Ltd | 08/06/2025SE |
| K252010 | SPY LaparoscopeGCJ · Special | Stryker Endoscopy | 07/24/2025SE |
| K250820 | Disposable TrocarsGCJ · Traditional | Sinolinks Medical Innovation, Inc. | 07/11/2025SE |
| K251490 | 8 mm Assist Cannula; 12 mm Assist CannulaGCJ · Traditional | Intuitive Surgical, Inc. | 07/02/2025SE |
| K243399 | Boehringer Laboratories Liver RetractorGCJ · Traditional | Boehringer Laboratories, LLC | 07/02/2025SE |
| K251209 | Medical Monitor (32HS710S)GCJ · Traditional | Lg Electronics.Inc | 06/12/2025SE |
| K250728 | Arthrex Synergy Vision Endoscopic Imaging SystemGCJ · Traditional | Arthrex, Inc. | 05/05/2025SE |
| K243867 | LAGIS Suction Irrigation SystemGCJ · Traditional | Lagis Enterprise Co., Ltd. | 03/17/2025SE |
| K250411 | DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval SystemGCJ · Traditional | Dannik, LLC | 03/12/2025SE |
| K243439 | Medical Monitor (27HS714S)GCJ · Traditional | Lg Electronics.Inc | 01/28/2025SE |
| K243008 | Arthrex NanoScope SystemGCJ · Traditional | Arthrex, Inc. | 01/22/2025SE |
| K243307 | LCD Monitor (MDEC-2523)GCJ · Traditional | Barco N.V. | 12/13/2024SE |
| K242927 | Suction Irrigation Tubing SetGCJ · Traditional | Advamedix, GmbH | 11/22/2024SE |
| K240831 | MultiCut SoloGCJ · Special | Asclepion Laser Technologies GmbH | 11/06/2024SE |
| K240334 | LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D…GCJ · Traditional | Lagis Enterprise Co., Ltd. | 10/30/2024SE |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE…GCJ · Traditional | Guangdong Optomedic Technologies, Inc. | 10/23/2024SE |
| K241796 | TroCare TroKit Laparoscope Lens Wiper (CP000626)GCJ · Traditional | TroCare, LLC | 10/04/2024SE |
| K241052 | Bladeless Trocar; Bladed Trocar; Hasson TrocarGCJ · Traditional | Advamedix, GmbH | 10/04/2024SE |
| K241913 | da Vinci Handheld CameraGCJ · Traditional | Intuitive Surgical Operations, Inc. | 08/28/2024SE |
| K241401 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with…GCJ · Traditional | Stryker Endoscopy | 08/15/2024SE |
| K241402 | Medical Monitor (32HR734S)GCJ · Traditional | Lg Electronics.Inc | 08/12/2024SE |
| K241530 | Stellar Imaging SystemGCJ · Traditional | Guangdong Optomedic Technologies, Inc. | 08/07/2024SE |
| K241360 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 08/05/2024SE |
| K241361 | Arthrex Synergy Vision Endoscopic Imaging SystemGCJ · Traditional | Arthrex, Inc. | 07/25/2024SE |
| K241502 | P-ScopeGCJ · Traditional | Oui Medical, Inc. | 07/24/2024SE |
| K241739 | Endoscopic Applicator, 41 cmGCJ · Special | Micromedics, Inc. | 07/15/2024SE |
| K241111 | AMT Suture PasserGCJ · Traditional | Applied Medical Technology, Inc. | 07/05/2024SE |
| K233840 | Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)GCJ · Traditional | Zhuhai Dipu Medical Technology Co., Ltd. | 06/26/2024SE |
| K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…GCJ · Traditional | Schoelly Fiberoptic GmbH | 06/20/2024SE |
| K240196 | Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)GCJ · Traditional | Yuwonmeditech Co., Ltd. | 06/18/2024SE |
| K233892 | 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)GCJ · Traditional | Zhuhai Dipu Medical Technology Co., Ltd. | 06/13/2024SE |
| K233386 | Monik - Disposable Endoscopic TrocarGCJ · Traditional | M/s. Meril Endo Surgery Private Limited. | 05/24/2024SE |
| K240205 | Ez Catch Auto; Ez Catch YR; Ez Catch TRGCJ · Traditional | Veol Medical Technologies Pvt , Ltd. | 04/15/2024SE |
| K233263 | Disposable TrocarsGCJ · Traditional | Hangzhou Kangji Medical Instrument Co., Ltd. | 04/09/2024SE |
| K240635 | ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm…GCJ · Special | Ximedica | 04/01/2024SE |
| K240174 | 1688 4K Camera System with Advanced Imaging ModalityGCJ · Special | Stryker Endoscopy | 02/22/2024SE |
| K233451 | Arthrex Synergy Vision Endoscopic Imaging SystemGCJ · Traditional | Arthrex, Inc. | 01/18/2024SE |
| K222783 | MD Mattress Suture Placement DeviceGCJ · Traditional | Lsi Solutions, Inc. | 01/12/2024SE |
| K233327 | 1788 4K Camera System with Advanced Imaging ModalityGCJ · Special | Stryker Endoscopy | 01/09/2024SE |
| K232519 | ENDOCOLLECT Specimen Retrieval BagGCJ · Traditional | Ximedica | 01/05/2024SE |
| K231066 | CuratOR EX3242-FDGCJ · Traditional | Eizo Corporation | 12/18/2023SE |
| K232866 | Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)GCJ · Traditional | Jiangsu Channel Medical Device Co., Ltd. | 11/07/2023SE |
| K232880 | Inzii Ripstop Redeployable Retrieval SystemGCJ · Special | Applied Medical Resources Corporation | 11/01/2023SE |
| K232042 | NexPort Trocar System (TS211001); NexPort Trocar System (TS211002); NexPort Trocar…GCJ · Traditional | Mediconcepts Technology (Shenzhen) Company Limited | 10/20/2023SE |
| K231725 | Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)GCJ · Traditional | Hunan Endoso Life Technology Co., Ltd. | 10/16/2023SE |
| K232701 | Guardenia (GAR-1)GCJ · Special | Advanced Surgical Concepts | 09/29/2023SE |
| K231622 | REGER Nebulizer Irrigation CannulaGCJ · Traditional | Reger Medizintechnik, GmbH | 09/29/2023SE |
| K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…GCJ · Special | Stryker Corporation | 08/18/2023SE |
| K231400 | Bladeless Trocar Artemis Lap CannulaGCJ · Special | T.A.G. Medical Products Corporation, Ltd. | 08/04/2023SE |
| K231003 | Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)GCJ · Traditional | Guangdong Optomedic Technologies, Inc. | 07/06/2023SE |
| K231358 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/05/2023SE |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP)…GCJ · Traditional | Karl Storz Endoscopy America, Inc. | 06/23/2023SE |
| K230886 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with…GCJ · Special | Stryker Endoscopy | 06/21/2023SE |
| K231042 | Disposable Laparoscopic TrocarGCJ · Traditional | Changzhou Ankang Medical Instruments Co., Ltd. | 06/08/2023SE |
| K223718 | HandX Self-Righting Needle HolderGCJ · Traditional | Human Xtensions , Ltd. | 06/05/2023SE |
| K223562 | Xpan Universal Trocar SystemGCJ · Traditional | Xpan, Inc. | 06/02/2023SE |
| K230491 | HandX Monopolar ScissorsGCJ · Traditional | Human Xtensions , Ltd. | 05/10/2023SE |
| K230058 | Bladeless Trocar Artemis Lap CannulaGCJ · Traditional | T.A.G. Medical Products Corporation, Ltd. | 04/28/2023SE |
| K230605 | 1788 4K Camera System with Advanced Imaging ModalityGCJ · Special | Stryker | 03/31/2023SE |
| K223923 | HOPKINS TelescopesGCJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/30/2023SE |
| K223593 | Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical TrocarGCJ · Traditional | Taiwan Surgical Corporation | 03/22/2023SE |
| K222828 | Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B…GCJ · Traditional | Wickimed (Huizhou) Medical Equipment… | 03/20/2023SE |
| K223116 | 8X-10-6XXX Camera HeadGCJ · Traditional | Santa Barbara Imaging Systems | 02/28/2023SE |
| K223759 | Arthrex SynergyID Endoscopic Imaging SystemGCJ · Traditional | Arthex, Inc. | 02/24/2023SE |
| K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)GCJ · Special | Stryker | 02/23/2023SE |
| K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…GCJ · Traditional | Schoelly Fiberoptic GmbH | 02/23/2023SE |
| K221861 | FloNavi Endoscopic Fluorescence Imaging SystemGCJ · Traditional | Guangdong Optomedic Technologies, Inc. | 02/18/2023SE |
| K221781 | Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KHGCJ · Traditional | Guangdong Optomedic Technologies, Inc. | 02/02/2023SE |
| K213597 | MultiCut SoloGCJ · Traditional | Asclepion Laser Technologies GmbH | 01/18/2023SE |
| K221252 | Scivita 4KINSIGHT ICG Imaging SystemGCJ · Traditional | Scivita Medical Technology Co., Ltd. | 01/13/2023SE |
| K222011 | HandX Instrument - Monopolar SpatulaGCJ · Special | Human Xtensions , Ltd. | 01/12/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | Karl Storz Endoscopy America, Inc. | 12/20/2022SE |
| K222575 | HurriChem Device KitGCJ · Traditional | Thermasolutions, LLC | 12/06/2022SE |
| K212736 | Canady Flex RoboWristGCJ · Traditional | Us Medical Innovations, LLC | 11/22/2022SE |
| K222504 | H1GCJ · Traditional | Karl Storz Endoscopy America, Inc. | 11/10/2022SE |
| K221740 | Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…GCJ · Traditional | Smith and Nephew, Inc. | 10/20/2022SE |
| K222890 | Radiance Ultra 32 4K Zerowire DuoGCJ · Special | Nds Surgical Imaging, LLC | 10/19/2022SE |
| K222079 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…GCJ · Traditional | Stryker Endoscopy | 10/11/2022SE |
| K221533 | Plasma ShieldGCJ · Traditional | Plasmatica, Ltd. | 09/12/2022SE |
| K221365 | LapBox Tissue Containment Removal SystemGCJ · Traditional | Ark Surgical, Ltd. | 08/25/2022SE |
| K222130 | 1688 4K Camera System with Advanced Imaging ModalityGCJ · Special | Stryker | 08/19/2022SE |
| K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation…GCJ · Traditional | Covidien | 06/27/2022SE |
| K211148 | CORE-TrocarGCJ · Traditional | Incore Co., Ltd. | 06/21/2022SE |
| K221217 | SPY LaparoscopeGCJ · Traditional | Stryker | 06/17/2022SE |
| K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableGCJ · Traditional | Stryker | 05/25/2022SE |
| K220895 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…GCJ · Special | Stryker | 04/22/2022SE |
| K220872 | Saberscope5 LaparoscopeGCJ · Special | Xenocor, Inc. | 04/20/2022SE |
| K211043 | Alexis Contained Extraction SystemGCJ · Traditional | Applied Medical Resources Corporation | 03/31/2022SE |
| K213860 | ArthroFree Wireless Surgical Camera SystemGCJ · Traditional | Lazurite Holdings, LLC | 03/23/2022SE |
| K220069 | 4K UHD LCD Monitor OEV321UHGCJ · Traditional | Olympus Medical Systems Corp. | 03/09/2022SE |
| K220108 | SDC4K Information Management System with Device and Voice Control PackageGCJ · Special | Stryker Endoscopy | 02/09/2022SE |
| K212055 | Connected OR Hub with Device and Voice ControlGCJ · Traditional | Stryker Corporation | 12/16/2021SE |
| K212500 | ArtiSential TrocarGCJ · Traditional | Livsmed, Inc. | 12/03/2021SE |
| K212950 | FUJIFILM Video Laparoscope EL-R740M30GCJ · Traditional | Fujifilm Corporaton | 12/02/2021SE |
| K211577 | SoftFix Balloon TrocarGCJ · Traditional | Unimax Medical Systems, Inc. | 11/05/2021SE |
| K212511 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…GCJ · Traditional | Stryker | 11/04/2021SE |
| K211234 | RedExGCJ · Traditional | Advanced Surgical Concepts, Ltd. | 09/17/2021SE |
| K212214 | HandXGCJ · Traditional | Human Xtensions , Ltd. | 09/13/2021SE |
| K210248 | Lab Bag with Fabric PouchGCJ · Traditional | Advanced Medical Design Co., Ltd. | 07/30/2021SE |
| K202582 | Arthrex SynergyID Endoscopic Imaging SystemGCJ · Traditional | Arthrex, Inc. | 07/22/2021SE |
| K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0GCJ · Traditional | Fujifilm Corporaton | 06/30/2021SE |
| K202551 | Cor-Knot MicroGCJ · Traditional | Lsi Solutions, Inc. | 06/24/2021SE |
| K211250 | VisionPort SystemGCJ · Traditional | New View Surgical, Inc. | 06/21/2021SE |
| K210495 | Port Access SystemGCJ · Traditional | Surgical Innovations Limited | 06/18/2021SE |
| K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…GCJ · Traditional | Stryker | 04/13/2021SE |
| K210584 | SDC3 HD Information Management System with Wireless Device Control CapabilityGCJ · Special | Stryker | 03/18/2021SE |
| K203255 | 4K UHD LaparoscopeGCJ · Traditional | Scivita Medical Technology Co., Ltd. | 02/24/2021SE |
| K202303 | CORE E3 Suction/irrigatorGCJ · Traditional | Conmed Corporation | 02/19/2021SE |
| K203603 | Monopolar HookGCJ · Traditional | Human Xtensions , Ltd. | 02/01/2021SE |
| K201526 | TIPCAM1 Rubina Video Endoscope SystemGCJ · Traditional | Karl Storz Endoscopy America | 11/20/2020SE |
| K202931 | Disposable TrocarGCJ · Traditional | Wuxi Shukang Medical Appliance Co., Ltd. | 11/17/2020SE |
| K202592 | Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…GCJ · Special | Stryker | 10/08/2020SE |
| K201134 | Arthrex NanoScope SystemGCJ · Traditional | Arthrex, Inc. | 09/04/2020SE |
| K201805 | VersaOne Reusable Positioning Trocar SystemGCJ · Traditional | Covidien | 08/26/2020SE |
| K202130 | FUJIFILM Video LaparoscopeGCJ · Special | Fujifilm Corporation | 08/20/2020SE |
| K201641 | Disposable Laparoscope TrocarGCJ · Traditional | Beijing Biosis Healing Biolog Ical Technology… | 08/06/2020SE |
| K192499 | Cyber BladeGCJ · Traditional | SIDAM S.r.l. | 07/31/2020SE |
| K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device ControlGCJ · Traditional | Stryker | 07/28/2020SE |
| K201198 | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, AutoclavableGCJ · Traditional | Smith & Nephew | 07/17/2020SE |
| K201243 | Disposable Specimen Retrieval BagGCJ · Traditional | Beijing Biosis Healing Biolog Ical Technology… | 07/10/2020SE |
| K193272 | GTK TrocarsGCJ · Traditional | Guangzhou T.K Medical Instrument Co., Ltd. | 07/09/2020SE |
| K201593 | Looking Glass 4K Integrated Visualization SystemGCJ · Special | Conmed Corporation | 07/08/2020SE |
| K201151 | O-Mec 690 Series LaparoscopesGCJ · Traditional | Omec Medical, Inc. | 06/22/2020SE |
| K200902 | ClickCleanGCJ · Special | Medeon Biodesign, Inc. | 04/30/2020SE |
| K191866 | GelPOINT Mini Advanced Access PlatformGCJ · Traditional | Applied Medical | 04/29/2020SE |
| K200053 | DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval…GCJ · Traditional | Dannik | 04/21/2020SE |
| K193161 | Pristine ScopeGCJ · Traditional | Pristine Surgical | 04/21/2020SE |
| K191930 | 7 mm Extended Length EndoscopeGCJ · Traditional | Maquet Cardiovascular, LLC | 04/15/2020SE |
| K200517 | Standard TrocarGCJ · Traditional | Standard Bariatrics | 04/09/2020SE |
| K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye 3DGCJ · Traditional | Olympus Medical Systems Corp. | 04/03/2020SE |
| K192300 | EnlightenVue Microendoscopy SystemGCJ · Traditional | Enlightenvue, Inc. | 03/20/2020SE |
| K200310 | 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…GCJ · Special | Stryker | 03/06/2020SE |
| K192918 | Video Laparoscope, Video Processor, Light SourceGCJ · Traditional | Fujifilm Corporation | 02/20/2020SE |
| K200228 | ClearCam SystemGCJ · Traditional | Clearcam, LLC | 02/19/2020SE |
| K193315 | Xenocor Articulating Xenoscope LaparoscopeGCJ · Special | Xenocor, Inc. | 01/27/2020SE |
| K191678 | IP ConverterGCJ · Traditional | Sony Electronics, Inc. | 01/10/2020SE |
| K193137 | EASYGRIP FLO-41 Precision MIS Delivery SystemGCJ · Traditional | Baxter Healthcare Corportation | 01/08/2020SE |
| K192643 | Dannik Laparoscopic Suction Irrigation SystemGCJ · Traditional | Dannik | 11/19/2019SE |
| K192891 | Laparoscope Lens Shield Device (LENS)GCJ · Special | Medeon Biodesign, Inc. | 11/07/2019SE |
| K190029 | Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar…GCJ · Traditional | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 09/26/2019SE |
| K183675 | 3D Visualization SystemGCJ · Traditional | Scivita Medical Technology Co., Ltd. | 09/25/2019SE |
| K192172 | Connected OR Hub with Device and Voice ControlGCJ · Special | Stryker | 09/09/2019SE |
| K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…GCJ · Traditional | Smith and Nephew, Inc. | 08/23/2019SE |
| K191295 | Percutaneous Introducer NeedleGCJ · Traditional | Progressive Medical, Inc. | 08/06/2019SE |
| K190645 | Arthrex NanoScope SystemGCJ · Traditional | Arthrex, Inc. | 07/05/2019SE |
| K191043 | da Vinci Handheld CameraGCJ · Traditional | Intuitive Surgical, Inc. | 06/06/2019SE |
| K190831 | E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD…GCJ · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 05/31/2019SE |
| K190592 | YelloPort Elite Port Access SystemGCJ · Traditional | Surgical Innovations Limited | 04/29/2019SE |
| K190788 | Disposable Standard ClampGCJ · Special | Standard Bariatrics | 04/18/2019SE |
| K181173 | ELMED Laparoscopic Instruments and AccessoriesGCJ · Traditional | Elmed Incorporated | 03/22/2019SE |
| K183600 | Anchor Bag-Alone Tissue Retrieval System by ConMedGCJ · Traditional | Conmed Corporation | 03/13/2019SE |
| K183264 | Flex-THOR scopeGCJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/18/2019SE |
| K182434 | LaparoGuardGCJ · Traditional | Mariner Endosurgery, Inc. | 12/13/2018SE |
| K182606 | PINPOINT Endoscopic Fluorescence Imaging SystemGCJ · Traditional | Novadaq Technologies Ulc. (Now A Part of Stryker) | 11/21/2018SE |
| K173917 | neoClose PDSGCJ · Traditional | Neosurgical, Ltd. | 11/08/2018SE |
| K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…GCJ · Traditional | Stryker | 11/05/2018SE |
| K181258 | ConnectedOR Hub with Device and Voice ControlGCJ · Traditional | Stryker | 11/05/2018SE |
| K181608 | Disposable Standard ClampGCJ · Traditional | Standard Bariatrics | 09/27/2018SE |
| K182080 | Scope Antifogging SystemGCJ · Traditional | Xodus Medical, Inc. | 09/19/2018SE |
| K173822 | Anchor Tissue Retrieval System by CONMEDGCJ · Traditional | Conmed Corporation | 09/11/2018SE |
| K182024 | Dissecting Balloon SystemGCJ · Traditional | Applied Medical Resources Corp. | 08/30/2018SE |
| K181791 | Simplystrong, SimplyezeeGCJ · Traditional | Genicon, Inc. | 08/21/2018SE |
| K181395 | Universal Cannula Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/27/2018SE |
| K180977 | KARL STORZ New Generation TrocarsGCJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 07/18/2018SE |
| K180836 | GenistrongGCJ · Special | Genicon, Inc. | 04/18/2018SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2761-2026 Class II | Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual…Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image… | Olympus Corporation of the Americas | 07/07/2026Open, Classified |
| Z-1010-2026 Class II | Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23There is the potential for extended length of the blade obturator after assembly into the cannula and seal… | Applied Medical Resources Corp | 12/11/2025Open, Classified |
| Z-0312-2026 Class II | Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog…It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | Aesculap Inc | 09/24/2025Open, Classified |
| Z-0311-2026 Class II | Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog…It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | Aesculap Inc | 09/24/2025Open, Classified |
| Z-0310-2026 Class II | Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number:…It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | Aesculap Inc | 09/24/2025Open, Classified |
| Z-0309-2026 Class II | Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER…It was determined there is the potential of silicone fragments detaching from the yellow sealing component. | Aesculap Inc | 09/24/2025Open, Classified |
| Z-2170-2025 Class II | Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without…Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery… | Stryker Corporation | 06/18/2025Open, Classified |
| Z-3164-2024 Class II | 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6"…The tube may fall into the surgical site during the grasping process. | Unimax Medical Systems Inc | 06/25/2024Open, Classified |
| Z-2408-2024 Class II | Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number:…A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile… | Canadian Hospital Specialties Ltd. | 06/11/2024Open, Classified |
| Z-2221-2024 Class II | Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection…The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the… | Aspen Surgical | 06/03/2024Completed |
| Z-1471-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | Covidien, LP | 02/28/2024Open, Classified |
| Z-1470-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | Covidien, LP | 02/28/2024Open, Classified |
| Z-1469-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | Covidien, LP | 02/28/2024Open, Classified |
| Z-1468-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | Covidien, LP | 02/28/2024Open, Classified |
| Z-1467-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | Covidien, LP | 02/28/2024Open, Classified |
| Z-1466-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | Covidien, LP | 02/28/2024Open, Classified |
| Z-1465-2024 Class II | Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SBThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | Covidien, LP | 02/28/2024Open, Classified |
| Z-1247-2024 Class II | DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.The sterile blister packaging may be damaged, and sterility may be compromised. | Aesculap Inc | 01/09/2024Open, Classified |
| Z-1246-2024 Class II | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic…The sterile blister packaging may be damaged, and sterility may be compromised. | Aesculap Inc | 01/09/2024Open, Classified |
| Z-1245-2024 Class II | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic…The sterile blister packaging may be damaged, and sterility may be compromised. | Aesculap Inc | 01/09/2024Open, Classified |
| Z-1244-2024 Class II | DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.The sterile blister packaging may be damaged, and sterility may be compromised. | Aesculap Inc | 01/09/2024Open, Classified |
| Z-1243-2024 Class II | DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic…The sterile blister packaging may be damaged, and sterility may be compromised. | Aesculap Inc | 01/09/2024Open, Classified |
| Z-0985-2024 Class II | Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box…Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays. | CooperSurgical, Inc. | 08/29/2023Open, Classified |
| Z-2429-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 45CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2428-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2427-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2426-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 45CM, RATCHETED…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2425-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2424-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2423-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2422-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2421-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2420-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2419-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2418-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2417-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2416-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-2415-2023 Class II | Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF…Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to… | Carefusion 2200 Inc | 07/13/2023Open, Classified |
| Z-1602-2023 Class II | YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileROptical Trocars sterility assurance can not be guaranteed | Surgical Innovations Ltd | 03/28/2023Open, Classified |
| Z-1601-2023 Class II | YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileROptical Trocars sterility assurance can not be guaranteed | Surgical Innovations Ltd | 03/28/2023Open, Classified |
| Z-1465-2023 Class II | VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STSThere is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the… | Covidien LP | 03/22/2023Open, Classified |
| Z-1464-2023 Class II | VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STSThere is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the… | Covidien LP | 03/22/2023Open, Classified |
| Z-1463-2023 Class II | VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STSThere is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the… | Covidien LP | 03/22/2023Open, Classified |
| Z-1387-2023 Class II | Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5…Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may… | Covidien, LP | 03/01/2023Open, Classified |
| Z-1457-2022 Class II | X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System…The device may potentially cause a fire, leading to a safety risk. | Davol, Inc. | 06/27/2022Open, Classified |
| Z-1305-2022 Class II | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm…The product is not able to provide irrigation. | Davol, Inc. | 06/07/2022Open, Classified |
| Z-1304-2022 Class II | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle…The product is not able to provide irrigation. | Davol, Inc. | 06/07/2022Open, Classified |
| Z-1396-2022 Class II | YelloPort Elite Universal Seal. For use in laparoscopic procedures.There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may… | Surgical Innovations Ltd | 06/02/2022Completed |
| Z-1853-2022 Class II | Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic…Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Surgical Innovations Ltd | 01/20/2022Open, Classified |
| Z-1852-2022 Class II | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite…Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Surgical Innovations Ltd | 01/20/2022Open, Classified |