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
Feb 23, 2023K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
Stryker
GCJ
Feb 23, 2023K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
Schoelly Fiberoptic GmbH, DE
GCJ
Feb 18, 2023K221861FloNavi Endoscopic Fluorescence Imaging System
Guangdong Optomedic Technologies, Inc., CN
GCJ
Feb 2, 2023K221781Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
Guangdong Optomedic Technologies, Inc., CN
GCJ
Jan 18, 2023K213597MultiCut Solo
Asclepion Laser Technologies GmbH, DE
GCJ
Jan 13, 2023K221252Scivita 4KINSIGHT ICG Imaging System
Scivita Medical Technology Co., Ltd., CN
GCJ
Jan 12, 2023K222011HandX Instrument - Monopolar Spatula
Human Xtensions , Ltd., IL
GCJ
Dec 20, 2022K221004HOPKINS Telescopes
Karl Storz Endoscopy America, Inc.
GCJ
Dec 6, 2022K222575HurriChem Device Kit
Thermasolutions, LLC
GCJ
Nov 22, 2022K212736Canady Flex RoboWrist
Us Medical Innovations, LLC
GCJ
Nov 10, 2022K222504H1
Karl Storz Endoscopy America, Inc.
GCJ
Oct 20, 2022K221740SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UN
Smith and Nephew, Inc.
GCJ
Oct 19, 2022K222890RADIANCE ULTRA 32 4K ZEROWIRE DUO
Nds Surgical Imaging, LLC
GCJ
Oct 11, 2022K222079Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
Stryker Endoscopy
GCJ
Sep 12, 2022K221533Plasma Shield
Plasmatica, Ltd., IL
GCJ
Aug 25, 2022K221365LapBox Tissue Containment Removal System
Ark Surgical, Ltd., IL
GCJ
Aug 19, 2022K2221301688 4K Camera System with Advanced Imaging Modality
Stryker
GCJ
Jun 27, 2022K213818VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
Covidien
GCJ
Jun 21, 2022K211148CORE-Trocar
Incore Co., Ltd., KR
GCJ
Jun 17, 2022K221217SPY Laparoscope
Stryker
GCJ
May 25, 2022K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable
Stryker
GCJ
Apr 22, 2022K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
Stryker
GCJ
Apr 20, 2022K220872Saberscope5 Laparoscope
Xenocor, Inc.
GCJ
Mar 31, 2022K211043Alexis Contained Extraction System
Applied Medical Resources Corporation
GCJ
Mar 23, 2022K213860ArthroFree Wireless Surgical Camera System
Lazurite Holdings, LLC
GCJ
Mar 9, 2022K2200694K UHD LCD Monitor OEV321UH
Olympus Medical Systems Corp., JP
GCJ
Feb 9, 2022K220108SDC4K Information Management System with Device and Voice Control Package
Stryker Endoscopy
GCJ
Dec 16, 2021K212055Connected OR Hub with Device and Voice Control
Stryker Corporation
GCJ
Dec 3, 2021K212500ArtiSential Trocar
Livsmed, Inc., KR
GCJ
Dec 2, 2021K212950FUJIFILM Video Laparoscope EL-R740M30
Fujifilm Corporaton, JP
GCJ
Nov 5, 2021K211577SoftFix Balloon Trocar
Unimax Medical Systems, Inc., TW
GCJ
Nov 4, 2021K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (16884101
Stryker
GCJ
Sep 17, 2021K211234RedEx
Advanced Surgical Concepts, Ltd., IE
GCJ
Sep 13, 2021K212214HandX
Human Xtensions , Ltd., IL
GCJ
Jul 30, 2021K210248Lab Bag with Fabric Pouch
Advanced Medical Design Co., Ltd., TW
GCJ
Jul 22, 2021K202582Arthrex SynergyID Endoscopic Imaging System
Arthrex, Inc.
GCJ
Jun 30, 2021K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
Fujifilm Corporaton, JP
GCJ
Jun 24, 2021K202551Cor-Knot Micro
Lsi Solutions, Inc.
GCJ
Jun 21, 2021K211250VisionPort System
New View Surgical, Inc.
GCJ
Jun 18, 2021K210495Port Access System
Surgical Innovations Limited, GB
GCJ
Apr 13, 2021K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes
Stryker
GCJ
Mar 18, 2021K210584SDC3 HD Information Management System with Wireless Device Control Capability
Stryker
GCJ
Feb 24, 2021K2032554K UHD Laparoscope
Scivita Medical Technology Co., Ltd., CN
GCJ
Feb 19, 2021K202303CORE E3 Suction/irrigator
Conmed Corporation
GCJ
Feb 1, 2021K203603Monopolar Hook
Human Xtensions , Ltd., IL
GCJ
Nov 20, 2020K201526TIPCAM1 Rubina Video Endoscope System
Karl Storz Endoscopy America
GCJ
Nov 17, 2020K202931Disposable Trocar
Wuxi Shukang Medical Appliance Co., Ltd., CN
GCJ
Oct 8, 2020K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adava
Stryker
GCJ
Sep 4, 2020K201134Arthrex NanoScope System
Arthrex, Inc.
GCJ
Aug 26, 2020K201805VersaOne Reusable Positioning Trocar System
Covidien
GCJ

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