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
Oct 14, 2026K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld C
Intuitive Surgical, Inc.
GCJ
Sep 11, 2026K262397CuratOR EX2742
Eizo Corporation, JP
GCJ
Sep 1, 2026K260884UNIDRIVE Select System
Karl Storz SE & CO. KG, DE
GCJ
Aug 26, 2026K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor
Sony Corporation, JP
GCJ
Aug 13, 2026K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
Freyja Healthcare, LLC
GCJ
Jul 24, 2026K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Devic
Medical Impact, KR
GCJ
Jul 17, 2026K261614LED LCD Monitor (OEV-271H)
Lg Electronics.Inc, KR
GCJ
Jul 14, 2026K261249Universal Seal (5-12 mm)
Intuitive Surgical, Inc.
GCJ
Jun 11, 2026K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-
FloShield, Inc.
GCJ
Jun 10, 2026K260414“Tech-Image” Video Endoscope System
Tech-Image CO., LTD., TW
GCJ
Jun 4, 2026K253994TroKit Laparoscope Lens Wiper
TroCare, LLC
GCJ
Jun 2, 2026K252532Inno-Port Disposable Bladed Trocar
Taiwan Surgical Corporation, TW
GCJ
May 26, 2026K2603184K NIR/ICG Imaging System
Zhejiang Healnoc Technology Co., Ltd., CN
GCJ
May 24, 2026K260183MediBot Needle Driver Uno
Parallel Robotics, LLC
GCJ
May 19, 2026K252985Laport
Sejong Medical Co., Ltd., KR
GCJ
May 11, 2026K254228KARL STORZ Trocars with Valve Seals
Karl Storz SE & CO. KG
GCJ
Apr 30, 2026K2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
Kms Medical Technology Co., Ltd., CN
GCJ
Apr 8, 2026K260197Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
Suzhou Shenyun Medical Equipment Co., Ltd., CN
GCJ
Apr 8, 2026K260089TL-10 Laparoscopic Scope Cleaner
Scopix , Ltd., IL
GCJ
Feb 27, 2026K252714C-Lant Port
Vigor Medical Technologies , Ltd., IL
GCJ
Feb 24, 2026K253978Universal Seal (5-12 mm)
Intuitive Surgical, Inc.
GCJ
Feb 18, 2026K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
Stryker Endoscopy
GCJ
Feb 12, 2026K260177Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)
Xenocor, Inc.
GCJ
Jan 29, 2026K251923Medical Shaver System (Morcellator) (YSB-IIIA)
Hangzhou Hawk Optical Electronic Instruments Co., Ltd., CN
GCJ
Jan 23, 2026K252957Pneumo Dissector Hook
Ab Medica Sas, FR
GCJ
Jan 13, 2026K254014Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
Stryker Endoscopy
GCJ
Nov 22, 2025K250927KARL STORZ Cholangiography Set
Karl Storz SE & CO. KG, DE
GCJ
Nov 20, 2025K242606Nuvis® Wireless HD Camera System (Nuvis-2K)
Integrated Endoscopy, Inc.
GCJ
Oct 31, 2025K252442Kii Structural Balloon Access System
Applied Medical Resources Corp.
GCJ
Oct 29, 2025K2526973D Laparoscope
Guangdong Optomedic Technologies, Inc., CN
GCJ
Oct 20, 2025K252640VereSee Optical Veres Needle and Endoscopic Camera
Freyja Healthcare, LLC
GCJ
Oct 16, 2025K251994Arthrex Synergy Vision Imaging System
Arthrex, Inc.
GCJ
Oct 3, 2025K243968Revolve Surgical System
Revolve Surgical, Inc., CA
GCJ
Oct 2, 2025K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
Shenzhen Sophway Technology Co., Ltd., CN
GCJ
Sep 22, 2025K251743SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System
Surgical Principals, Inc.
GCJ
Aug 6, 2025K250130Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532
Hangzhou Viction Medical Technology Co.,Ltd, CN
GCJ
Aug 6, 2025K250124Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC05
Hangzhou Viction Medical Technology Co.,Ltd, CN
GCJ
Jul 24, 2025K252010SPY Laparoscope
Stryker Endoscopy
GCJ
Jul 11, 2025K250820Disposable Trocars
Sinolinks Medical Innovation, Inc., CN
GCJ
Jul 2, 2025K2514908 mm Assist Cannula; 12 mm Assist Cannula
Intuitive Surgical, Inc.
GCJ
Jul 2, 2025K243399Boehringer Laboratories Liver Retractor
Boehringer Laboratories, LLC
GCJ
Jun 12, 2025K251209Medical Monitor (32HS710S)
Lg Electronics.Inc, KR
GCJ
May 5, 2025K250728Arthrex Synergy Vision Endoscopic Imaging System
Arthrex, Inc.
GCJ
Mar 17, 2025K243867LAGIS Suction Irrigation System
Lagis Enterprise Co., Ltd., TW
GCJ
Mar 12, 2025K250411DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
Dannik, LLC
GCJ
Jan 28, 2025K243439Medical Monitor (27HS714S)
Lg Electronics.Inc, KR
GCJ
Jan 22, 2025K243008Arthrex NanoScope System
Arthrex, Inc.
GCJ
Dec 13, 2024K243307LCD Monitor (MDEC-2523)
Barco N.V., BE
GCJ
Nov 22, 2024K242927Suction Irrigation Tubing Set
Advamedix, GmbH, DE
GCJ
Nov 6, 2024K240831MultiCut Solo
Asclepion Laser Technologies GmbH, DE
GCJ

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