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)
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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
Apr 18, 2018K180836Genistrong
Genicon, Inc.
GCJ
Apr 9, 2018K180208Disposable Endoscopic Trocar
Fengh Medical Co., Ltd., CN
GCJ
Mar 27, 2018K180114AEON Retrieval Bag
Lexington Medical, Inc.
GCJ
Mar 20, 2018K173919HX Device
Human Extension , Ltd., IL
GCJ
Mar 19, 2018K180579Ezee Retrieval
Genicon, Inc.
GCJ
Mar 7, 2018K171939ALVUE Balloon Dilation System
Globus Medical, Inc.
GCJ
Feb 20, 2018K170683Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
Aesculap, Inc.
GCJ
Feb 9, 2018K173272Ergonomic Handle
Symmetry Surgical, Inc.
GCJ
Feb 1, 2018K172789Specimen Retrieval Bag
Beijing Hangtian Kadi Technology R&D Institute, CN
GCJ
Dec 7, 2017K172578Equipment Pouch
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd, CN
GCJ
Dec 5, 2017K172618SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
Olympus Medical Systems Corp., JP
GCJ
Nov 29, 2017K172794Suction Irrigation Set
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd, CN
GCJ
Oct 27, 2017K172038Trocar
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd, CN
GCJ
Oct 18, 2017K172940ANCHOR Tissue Retrieval System
Conmed Corporation
GCJ
Oct 6, 2017K172672Endoscopic Applicator, 41 cm
Micromedics, Inc. (D/B/A Nordson Medical)
GCJ
Sep 25, 2017K171726LapBag
Sejong Medical Co., Ltd., KR
GCJ
Aug 29, 2017K171741Laport
Sejong Medical Co., Ltd., KR
GCJ
Aug 17, 2017K171475DeRoyal Laprador Specimen Retrieval System
Deroyal Industries, Inc.
GCJ
Jul 19, 2017K170379Disposable Standard Clamp
Standard Bariatrics
GCJ
Jun 1, 2017K171344Xenocor Xenoscope Laparoscopic System
Xenocor, Inc.
GCJ
May 30, 2017K17089927HJ713S
Lg Electronics, KR
GCJ
Apr 7, 2017K170598ZeroWire Mobile
Nds Surgical Imaging, LLC
GCJ
Mar 13, 2017K170030NOVATECH TALCAIR
Novatech SA, FR
GCJ
Mar 13, 2017K162836FUJIFILM Surgical System
Fujifilm New Development U.S.A., Inc.
GCJ
Mar 10, 2017K170084InterLock Trocar
Fujifilm New Development U.S.A., Inc.
GCJ
Mar 8, 2017K163654VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closur
Covidien, LLC
GCJ
Feb 16, 2017K170103Laparoscope Lens Shield Device (LENS)
Medeon Biodesign, Inc., TW
GCJ
Jan 18, 2017K162197EndoClot
Endoclot Plus Co., Ltd., CN
GCJ
Jan 11, 2017K162387U-IGNITE Bladeless Trocar
Tianjin Uwell Medical Device Manufacturing Co., Ltd., CN
GCJ
Nov 30, 2016K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm
Covidien
GCJ
Nov 29, 2016K160801Well Lead Extraction Bag
Well Lead Medical Co., Ltd., CN
GCJ
Nov 22, 2016K153773Disposal Lens Cleaning Sheath
Olympus Medical Systems Corp., JP
GCJ
Oct 24, 2016K161720Standard Clamp
Standard Bariatrics
GCJ
Oct 20, 2016K162445LiVac Retractor System
Livac Pty, Ltd., AU
GCJ
Oct 18, 2016K162584VersaOne Bladeless Trocar
Covidien
GCJ
Sep 29, 2016K162059EZEE RETRIEVAL
Genicon, Inc.
GCJ
Sep 26, 2016K161838Xenocor Xenoscope Laparoscopic System
Xenocor, Inc.
GCJ
Sep 20, 2016K161792PINPOINT Endoscopic Fluorescence Imaging System
Novadaq Technologies, Inc., CA
GCJ
Sep 7, 2016K153542Pelican Sling Retractor
Beacon Surgical, Inc.
GCJ
Aug 11, 2016K162077Laparoscopic Spray Applicator with Spinning Luers
Micromedics, Inc. (D/B/A Nordson Medical)
GCJ
Jun 24, 2016K161421Single Use Surgical Suction Irrigator
Jiangsu Haize Medical Scientific Development Co., Ltd., CN
GCJ
Jun 8, 2016K161122Sony IP Converter NU-IP40S
Sony Electronics, Inc.
GCJ
Jun 2, 2016K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
Smith & Nephew
GCJ
May 26, 2016K161228Radiance Ultra Series ZeroWire Embedded
Nds Surgical Imaging, LLC
GCJ
May 26, 2016K160393AdTec
Aesculap, Inc.
GCJ
May 23, 2016K150956PINPOINT Endoscopic Fluorescence Imaging System
Novadaq Technologies, Inc., CA
GCJ
May 18, 2016K160332Stryker SDC3 HD Information Management System with Wireless Device Control Capability
Stryker Endoscopy
GCJ
May 9, 2016K161017True HD 3MOS Camera System
Conmed Corporation
GCJ
Apr 29, 2016K152619Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
Prosurg, Inc.
GCJ
Apr 21, 2016K160172Laparoscope Lens Shield Device
Medeon Biodesign, Inc., TW
GCJ

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