ClearanceBrief
Panels › Gastroenterology, Urology › Product code GCJ · Class 2

Laparoscope, General & Plastic Surgery

Regulation 876.1500

28510(k)s in 12 months (1,431 all time)
2recalls in 12 months (274 all time)
215recalls that name a 510(k)
Get daily alerts for GCJSample briefCSV

Top companies in GCJ

Company510(k)sRecalls
Applied Medical Resources2635
Ethicon Endo-Surgery, Inc.3129
Conmed Corporation847
KARL STORZ Endoscopy-America, Inc.511
Origin Medsystems, Inc.340
Phx Technologies Corp.330
Stryker Endoscopy258
Covidien1318
United States Surgical, A Division of Tyco Healthc300
Richard Wolf Medical Instruments Corp.280
Decided510(k)Device and applicantCode
Aug 20, 2020K202130FUJIFILM Video Laparoscope
Fujifilm Corporation, JP
GCJ
Aug 6, 2020K201641Disposable Laparoscope Trocar
Beijing Biosis Healing Biolog Ical Technology Co., Ltd., CN
GCJ
Jul 31, 2020K192499Cyber Blade
SIDAM S.r.l., IT
GCJ
Jul 28, 2020K201434Connected OR Hub with Voice Control, Connected OR Hub with Device Control
Stryker
GCJ
Jul 17, 2020K201198S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
Smith & Nephew
GCJ
Jul 10, 2020K201243Disposable Specimen Retrieval Bag
Beijing Biosis Healing Biolog Ical Technology Co., Ltd., CN
GCJ
Jul 9, 2020K193272GTK Trocars
Guangzhou T.K Medical Instrument Co., Ltd., CN
GCJ
Jul 8, 2020K201593Looking Glass 4K Integrated Visualization System
Conmed Corporation
GCJ
Jun 22, 2020K201151O-Mec 690 Series Laparoscopes
Omec Medical, Inc.
GCJ
Apr 30, 2020K200902ClickClean
Medeon Biodesign, Inc., TW
GCJ
Apr 29, 2020K191866GelPOINT Mini Advanced Access Platform
Applied Medical
GCJ
Apr 21, 2020K200053DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
Dannik
GCJ
Apr 21, 2020K193161Pristine Scope
Pristine Surgical
GCJ
Apr 15, 2020K1919307 mm Extended Length Endoscope
Maquet Cardiovascular, LLC
GCJ
Apr 9, 2020K200517Standard Trocar
Standard Bariatrics
GCJ
Apr 3, 2020K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3D
Olympus Medical Systems Corp., JP
GCJ
Mar 20, 2020K192300EnlightenVue Microendoscopy System
Enlightenvue, Inc.
GCJ
Mar 6, 2020K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality
Stryker
GCJ
Feb 20, 2020K192918Video Laparoscope, Video Processor, Light Source
Fujifilm Corporation, JP
GCJ
Feb 19, 2020K200228ClearCam System
Clearcam, LLC
GCJ
Jan 27, 2020K193315Xenocor Articulating Xenoscope Laparoscope
Xenocor, Inc.
GCJ
Jan 10, 2020K191678IP Converter
Sony Electronics, Inc.
GCJ
Jan 8, 2020K193137EASYGRIP FLO-41 Precision MIS Delivery System
Baxter Healthcare Corportation
GCJ
Nov 19, 2019K192643Dannik Laparoscopic Suction Irrigation System
Dannik
GCJ
Nov 7, 2019K192891Laparoscope Lens Shield Device (LENS)
Medeon Biodesign, Inc., TW
GCJ
Sep 26, 2019K190029Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposabl
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd, CN
GCJ
Sep 25, 2019K1836753D Visualization System
Scivita Medical Technology Co., Ltd., CN
GCJ
Sep 9, 2019K192172Connected OR Hub with Device and Voice Control
Stryker
GCJ
Aug 23, 2019K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head
Smith and Nephew, Inc.
GCJ
Aug 6, 2019K191295Percutaneous Introducer Needle
Progressive Medical, Inc.
GCJ
Jul 5, 2019K190645Arthrex NanoScope System
Arthrex, Inc.
GCJ
Jun 6, 2019K191043da Vinci Handheld Camera
Intuitive Surgical, Inc.
GCJ
May 31, 2019K190831E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230
Nanjing Jusha Display Technology Co., Ltd., CN
GCJ
Apr 29, 2019K190592YelloPort Elite Port Access System
Surgical Innovations Limited, GB
GCJ
Apr 18, 2019K190788Disposable Standard Clamp
Standard Bariatrics
GCJ
Mar 22, 2019K181173ELMED Laparoscopic Instruments and Accessories
Elmed Incorporated
GCJ
Mar 13, 2019K183600Anchor Bag-Alone Tissue Retrieval System by ConMed
Conmed Corporation
GCJ
Jan 18, 2019K183264Flex-THOR scope
KARL STORZ Endoscopy-America, Inc.
GCJ
Dec 13, 2018K182434LaparoGuard
Mariner Endosurgery, Inc., CA
GCJ
Nov 21, 2018K182606PINPOINT Endoscopic Fluorescence Imaging System
Novadaq Technologies Ulc. (Now A Part of Stryker), CA
GCJ
Nov 8, 2018K173917neoClose PDS
Neosurgical, Ltd., IE
GCJ
Nov 5, 2018K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K C
Stryker
GCJ
Nov 5, 2018K181258ConnectedOR Hub with Device and Voice Control
Stryker
GCJ
Sep 27, 2018K181608Disposable Standard Clamp
Standard Bariatrics
GCJ
Sep 19, 2018K182080Scope Antifogging System
Xodus Medical, Inc.
GCJ
Sep 11, 2018K173822Anchor Tissue Retrieval System by CONMED
Conmed Corporation
GCJ
Aug 30, 2018K182024Dissecting Balloon System
Applied Medical Resources Corp.
GCJ
Aug 21, 2018K181791SIMPLYSTRONG, SIMPLYEZEE
Genicon, Inc.
GCJ
Jul 27, 2018K181395Universal Cannula Seal (5-12 mm)
Intuitive Surgical, Inc.
GCJ
Jul 18, 2018K180977KARL STORZ New Generation Trocars
KARL STORZ Endoscopy-America, Inc.
GCJ

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.