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 30, 2024K240334LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, D
Lagis Enterprise Co., Ltd., TW
GCJ
Oct 23, 2024K242513FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
Guangdong Optomedic Technologies, Inc., CN
GCJ
Oct 4, 2024K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)
TroCare, LLC
GCJ
Oct 4, 2024K241052Bladeless Trocar; Bladed Trocar; Hasson Trocar
Advamedix, GmbH, DE
GCJ
Aug 28, 2024K241913da Vinci Handheld Camera
Intuitive Surgical Operations, Inc.
GCJ
Aug 15, 2024K241401Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
Stryker Endoscopy
GCJ
Aug 12, 2024K241402Medical Monitor (32HR734S)
Lg Electronics.Inc, KR
GCJ
Aug 7, 2024K241530Stellar Imaging System
Guangdong Optomedic Technologies, Inc., CN
GCJ
Aug 5, 2024K241360Universal Seal (5-12 mm)
Intuitive Surgical, Inc.
GCJ
Jul 25, 2024K241361Arthrex Synergy Vision Endoscopic Imaging System
Arthrex, Inc.
GCJ
Jul 24, 2024K241502P-SCOPE
Oui Medical, Inc.
GCJ
Jul 15, 2024K241739Endoscopic Applicator, 41 cm
Micromedics, Inc.
GCJ
Jul 5, 2024K241111AMT Suture Passer
Applied Medical Technology, Inc.
GCJ
Jun 26, 2024K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)
Zhuhai Dipu Medical Technology Co., Ltd., CN
GCJ
Jun 20, 2024K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic s
Schoelly Fiberoptic GmbH, DE
GCJ
Jun 18, 2024K240196Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
Yuwonmeditech Co., Ltd., KR
GCJ
Jun 13, 2024K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)
Zhuhai Dipu Medical Technology Co., Ltd., CN
GCJ
May 24, 2024K233386Monik™ - Disposable Endoscopic Trocar
M/s. Meril Endo Surgery Private Limited., IN
GCJ
Apr 15, 2024K240205Ez Catch Auto; Ez Catch YR; Ez Catch TR
Veol Medical Technologies Pvt , Ltd., IN
GCJ
Apr 9, 2024K233263Disposable Trocars
Hangzhou Kangji Medical Instrument Co., Ltd., CN
GCJ
Apr 1, 2024K240635ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 1
Ximedica
GCJ
Feb 22, 2024K2401741688 4K Camera System with Advanced Imaging Modality
Stryker Endoscopy
GCJ
Jan 18, 2024K233451Arthrex Synergy Vision Endoscopic Imaging System
Arthrex, Inc.
GCJ
Jan 12, 2024K222783MD Mattress Suture Placement Device
Lsi Solutions, Inc.
GCJ
Jan 9, 2024K2333271788 4K Camera System with Advanced Imaging Modality
Stryker Endoscopy
GCJ
Jan 5, 2024K232519ENDOCOLLECT Specimen Retrieval Bag
Ximedica
GCJ
Dec 18, 2023K231066CuratOR EX3242-FD
Eizo Corporation, JP
GCJ
Nov 7, 2023K232866Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)
Jiangsu Channel Medical Device Co., Ltd., CN
GCJ
Nov 1, 2023K232880Inzii Ripstop Redeployable Retrieval System
Applied Medical Resources Corporation
GCJ
Oct 20, 2023K232042NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar
Mediconcepts Technology (Shenzhen) Company Limited, CN
GCJ
Oct 16, 2023K231725Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
Hunan Endoso Life Technology Co., Ltd., CN
GCJ
Sep 29, 2023K232701Guardenia (GAR-1)
Advanced Surgical Concepts, IE
GCJ
Sep 29, 2023K231622REGER Nebulizer Irrigation Cannula
Reger Medizintechnik, GmbH, DE
GCJ
Aug 18, 2023K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
Stryker Corporation
GCJ
Aug 4, 2023K231400Bladeless Trocar – Artemis Lap Cannula
T.A.G. Medical Products Corporation, Ltd., IL
GCJ
Jul 6, 2023K231003Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
Guangdong Optomedic Technologies, Inc., CN
GCJ
Jul 5, 2023K231358Universal Seal (5-12 mm)
Intuitive Surgical, Inc.
GCJ
Jun 23, 2023K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36
Karl Storz Endoscopy America, Inc.
GCJ
Jun 21, 2023K230886Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
Stryker Endoscopy
GCJ
Jun 8, 2023K231042Disposable Laparoscopic Trocar
Changzhou Ankang Medical Instruments Co., Ltd., CN
GCJ
Jun 5, 2023K223718HandX™ Self-Righting Needle Holder
Human Xtensions , Ltd., IL
GCJ
Jun 2, 2023K223562Xpan Universal Trocar System
Xpan, Inc., CA
GCJ
May 10, 2023K230491HandX™ Monopolar Scissors
Human Xtensions , Ltd., IL
GCJ
Apr 28, 2023K230058Bladeless Trocar – Artemis Lap Cannula
T.A.G. Medical Products Corporation, Ltd., IL
GCJ
Mar 31, 2023K2306051788 4K Camera System with Advanced Imaging Modality
Stryker
GCJ
Mar 30, 2023K223923HOPKINS Telescopes
KARL STORZ Endoscopy-America, Inc.
GCJ
Mar 22, 2023K223593Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
Taiwan Surgical Corporation, TW
GCJ
Mar 20, 2023K222828Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd, CN
GCJ
Feb 28, 2023K2231168X-10-6XXX Camera Head
Santa Barbara Imaging Systems
GCJ
Feb 24, 2023K223759Arthrex SynergyID Endoscopic Imaging System
Arthex, Inc.
GCJ

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