FDA.report

Product code GCJ

Current FDA Classification

Device name
Laparoscope, General & Plastic Surgery
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.1500
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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).

Related 510(k) Records

510(k)DeviceApplicantDecision date
K254228KARL STORZ Trocars with Valve SealsKarl Storz SE & CO. KG2026-05-11
K2528584K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)Kms Medical Technology Co., Ltd.2026-04-30
K260197Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)Suzhou Shenyun Medical Equipment Co., Ltd.2026-04-08
K260089TL-10 Laparoscopic Scope CleanerScopix , Ltd.2026-04-08
K252714C-Lant PortVigor Medical Technologies , Ltd.2026-02-27
K253978Universal Seal (5-12 mm)Intuitive Surgical, Inc.2026-02-24
K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy2026-02-18
K260177Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)Xenocor, Inc.2026-02-12
K251923Medical Shaver System (Morcellator) (YSB-IIIA)Hangzhou Hawk Optical Electronic Instruments Co., Ltd.2026-01-29
K252957Pneumo Dissector HookAb Medica Sas2026-01-23
K254014Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice ControlStryker Endoscopy2026-01-13
K250927KARL STORZ Cholangiography SetKarl Storz SE & CO. KG2025-11-22
K242606Nuvis® Wireless HD Camera System (Nuvis-2K)Integrated Endoscopy, Inc.2025-11-20
K252442Kii Structural Balloon Access SystemApplied Medical Resources Corp.2025-10-31
K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.2025-10-29
K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC2025-10-20
K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.2025-10-16
K243968Revolve Surgical SystemRevolve Surgical, Inc.2025-10-03
K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)Shenzhen Sophway Technology Co., Ltd.2025-10-02
K251743SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval SystemSurgical Principals, Inc.2025-09-22
K250130Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532)Hangzhou Viction Medical Technology Co.,Ltd2025-08-06
K250124Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)Hangzhou Viction Medical Technology Co.,Ltd2025-08-06
K252010SPY LaparoscopeStryker Endoscopy2025-07-24
K250820Disposable TrocarsSinolinks Medical Innovation, Inc.2025-07-11
K243399Boehringer Laboratories Liver RetractorBoehringer Laboratories, LLC2025-07-02
K2514908 mm Assist Cannula; 12 mm Assist CannulaIntuitive Surgical, Inc.2025-07-02
K251209Medical Monitor (32HS710S)Lg Electronics.Inc2025-06-12
K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.2025-05-05
K243867LAGIS Suction Irrigation SystemLagis Enterprise Co., Ltd.2025-03-17
K250411DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval SystemDannik, LLC2025-03-12

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00817428021551ModulapATC TECHNOLOGIES, INC.2026-03-20
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00607567700376Vasoview EVH Accsessory PackMAQUET CARDIOVASCULAR LLC2016-09-24