GCJ

Laparoscope, General & Plastic Surgery

Product code
GCJ
Device name
Laparoscope, General & Plastic Surgery
Device class
Class 2
21 CFR
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
80
Summaries archived here
69 (direct download)
510(k) clearances (all years, FDA)
1428 (all years; only the last 3 years are listed here)

FDA classification definition

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (80)

Last three years. Most recent: 2026-08-26.

NumberDecision dateApplicantDevice nameSummary
K2609722026-08-26Sony CorporationOEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-43…FDA
K2611392026-08-13Freyja Healthcare, LLCVereSee (VER150, VER200, VER151, VER201, VER200C, an…PDF
K2535412026-07-24Medical ImpactEZ-Close™ (EZ Close Port Site Closing Device, EZ Clo…FDA
K2616142026-07-17Lg Electronics.IncLED LCD Monitor (OEV-271H)PDF
K2612492026-07-14Intuitive Surgical, Inc.Universal Seal (5-12 mm)PDF
K2607102026-06-11FloShield, Inc.FloShield Air System (FSS-01-1000T - 10mm, 0 Degree …FDA
K2604142026-06-10Tech-Image CO., LTD.“Tech-Image” Video Endoscope SystemPDF
K2539942026-06-04TroCare, LLCTroKit Laparoscope Lens WiperPDF
K2525322026-06-02Taiwan Surgical CorporationInno-Port Disposable Bladed TrocarPDF
K2603182026-05-26Zhejiang Healnoc Technology Co., Ltd.4K NIR/ICG Imaging SystemPDF
K2601832026-05-24Parallel Robotics, LLCMediBot Needle Driver UnoPDF
K2529852026-05-19Sejong Medical Co., Ltd.LaportFDA
K2542282026-05-11Karl Storz SE & CO. KGKARL STORZ Trocars with Valve SealsPDF
K2528582026-04-30Kms Medical Technology Co., Ltd.4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-…PDF
K2600892026-04-08Scopix , Ltd.TL-10 Laparoscopic Scope CleanerPDF
K2601972026-04-08Suzhou Shenyun Medical Equipment Co., …Shogun Axis™ Fascial Closure System (1018S, 1018B, 1…PDF
K2527142026-02-27Vigor Medical Technologies , Ltd.C-Lant PortPDF
K2539782026-02-24Intuitive Surgical, Inc.Universal Seal (5-12 mm)PDF
K2601852026-02-18Stryker Endoscopy1688 4K Camera System with Advanced Imaging Modality…FDA
K2601772026-02-12Xenocor, Inc.Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video…PDF
K2519232026-01-29Hangzhou Hawk Optical Electronic Instr…Medical Shaver System (Morcellator) (YSB-IIIA)PDF
K2529572026-01-23Ab Medica SasPneumo Dissector HookPDF
K2540142026-01-13Stryker EndoscopyConnected OR Hub with Device and Voice Control; SDC4…FDA
K2509272025-11-22Karl Storz SE & CO. KGKARL STORZ Cholangiography SetPDF
K2426062025-11-20Integrated Endoscopy, Inc.Nuvis® Wireless HD Camera System (Nuvis-2K)FDA
K2524422025-10-31Applied Medical Resources Corp.Kii Structural Balloon Access SystemPDF
K2526972025-10-29Guangdong Optomedic Technologies, Inc.3D LaparoscopePDF
K2526402025-10-20Freyja Healthcare, LLCVereSee Optical Veres Needle and Endoscopic CameraPDF
K2519942025-10-16Arthrex, Inc.Arthrex Synergy Vision Imaging SystemPDF
K2439682025-10-03Revolve Surgical, Inc.Revolve Surgical SystemPDF
K2505512025-10-02Shenzhen Sophway Technology Co., Ltd.4K Endoscopic Camera System (SV-800, SV-800I, SV-800…PDF
K2517432025-09-22Surgical Principals, Inc.SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon…PDF
K2501302025-08-06Hangzhou Viction Medical Technology Co…Viction Disposable Irrigation and suction System (VC…PDF
K2501242025-08-06Hangzhou Viction Medical Technology Co…Viction Disposable Irrigation and suction catheter (…PDF
K2520102025-07-24Stryker EndoscopySPY LaparoscopePDF
K2508202025-07-11Sinolinks Medical Innovation, Inc.Disposable TrocarsPDF
K2433992025-07-02Boehringer Laboratories, LLCBoehringer Laboratories Liver RetractorPDF
K2514902025-07-02Intuitive Surgical, Inc.8 mm Assist Cannula; 12 mm Assist CannulaPDF
K2512092025-06-12Lg Electronics.IncMedical Monitor (32HS710S)PDF
K2507282025-05-05Arthrex, Inc.Arthrex Synergy Vision Endoscopic Imaging SystemPDF
K2438672025-03-17Lagis Enterprise Co., Ltd.LAGIS Suction Irrigation SystemPDF
K2504112025-03-12Dannik, LLCDANNIK® Laparoscopic Single-Use Poly Specimen Retrie…PDF
K2434392025-01-28Lg Electronics.IncMedical Monitor (27HS714S)PDF
K2430082025-01-22Arthrex, Inc.Arthrex NanoScope SystemFDA
K2433072024-12-13Barco N.V.LCD Monitor (MDEC-2523)PDF
K2429272024-11-22Advamedix, GmbHSuction Irrigation Tubing SetPDF
K2408312024-11-06Asclepion Laser Technologies GmbHMultiCut SoloPDF
K2403342024-10-30Lagis Enterprise Co., Ltd.LAGIS Endoscopic Instruments - Grasper (DI-5670-33D,…PDF
K2425132024-10-23Guangdong Optomedic Technologies, Inc.FloNavi Endoscopic Fluorescence Imaging System (OPTO…
K2417962024-10-04TroCare, LLCTroCare TroKit Laparoscope Lens Wiper (CP000626)PDF
K2410522024-10-04Advamedix, GmbHBladeless Trocar; Bladed Trocar; Hasson TrocarPDF
K2419132024-08-28Intuitive Surgical Operations, Inc.da Vinci Handheld CameraPDF
K2414012024-08-15Stryker EndoscopyConnected OR Hub with Device and Voice Control; SDC4…FDA
K2414022024-08-12Lg Electronics.IncMedical Monitor (32HR734S)PDF
K2415302024-08-07Guangdong Optomedic Technologies, Inc.Stellar Imaging SystemPDF
K2413602024-08-05Intuitive Surgical, Inc.Universal Seal (5-12 mm)PDF
K2413612024-07-25Arthrex, Inc.Arthrex Synergy Vision Endoscopic Imaging SystemPDF
K2415022024-07-24Oui Medical, Inc.P-SCOPEPDF
K2417392024-07-15Micromedics, Inc.Endoscopic Applicator, 41 cm
K2411112024-07-05Applied Medical Technology, Inc.AMT Suture PasserPDF
K2338402024-06-26Zhuhai Dipu Medical Technology Co., Lt…Endoscopic Fluorescence Camera System (DPM-ENDOCAM-0…PDF
K2332252024-06-20Schoelly Fiberoptic GmbHSCHOELLY Oxygen Saturation Imaging (OSI) Camera Syst…PDF
K2401962024-06-18Yuwonmeditech Co., Ltd.Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES…PDF
K2338922024-06-13Zhuhai Dipu Medical Technology Co., Lt…3D Endoscopic Fluorescence Camera System (DPM-ENDOCA…PDF
K2333862024-05-24M/s. Meril Endo Surgery Private Limite…Monik™ - Disposable Endoscopic TrocarPDF
K2402052024-04-15Veol Medical Technologies Pvt , Ltd.Ez Catch Auto; Ez Catch YR; Ez Catch TRPDF
K2332632024-04-09Hangzhou Kangji Medical Instrument Co.…Disposable TrocarsPDF
K2406352024-04-01XimedicaENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT…PDF
K2401742024-02-22Stryker Endoscopy1688 4K Camera System with Advanced Imaging ModalityPDF
K2334512024-01-18Arthrex, Inc.Arthrex Synergy Vision Endoscopic Imaging SystemPDF
K2227832024-01-12Lsi Solutions, Inc.MD Mattress Suture Placement DevicePDF
K2333272024-01-09Stryker Endoscopy1788 4K Camera System with Advanced Imaging ModalityPDF
K2325192024-01-05XimedicaENDOCOLLECT Specimen Retrieval BagPDF
K2310662023-12-18Eizo CorporationCuratOR EX3242-FDPDF
K2328662023-11-07Jiangsu Channel Medical Device Co., Lt…Disposable Abdominal Trocars (Bladed Trocars, Blade…PDF
K2328802023-11-01Applied Medical Resources CorporationInzii Ripstop Redeployable Retrieval SystemPDF
K2320422023-10-20Mediconcepts Technology (Shenzhen) Com…NexPort™ Trocar System (TS211001); NexPort™ Trocar S…PDF
K2317252023-10-16Hunan Endoso Life Technology Co., Ltd.Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA4…PDF
K2316222023-09-29Reger Medizintechnik, GmbHREGER Nebulizer Irrigation CannulaPDF
K2327012023-09-29Advanced Surgical ConceptsGuardenia (GAR-1)PDF

69 summaries are archived here for direct download.

Official FDA classification page: GCJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).