Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart B — Diagnostic Devices](/submissions/GU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 876.1500](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1500) → GCJ — Laparoscope, General & Plastic Surgery # GCJ · Laparoscope, General & Plastic Surgery _Gastroenterology, Urology · 21 CFR 876.1500 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ ## Overview - **Product Code:** GCJ - **Device Name:** Laparoscope, General & Plastic Surgery - **Regulation:** [21 CFR 876.1500](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1500) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) ## Identification An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Classification Rationale (1) Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. (2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. ## Special Controls *Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. ## Recent Cleared Devices (20 of 1414) Showing 20 most recent of 1414 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260197](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K260197.md) | Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) | Suzhou Shenyun Medical Equipment Co., Ltd. | Apr 8, 2026 | SESE | | [K260089](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K260089.md) | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | Apr 8, 2026 | SESE | | [K252714](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K252714.md) | C-Lant Port | Vigor Medical Technologies , Ltd. | Feb 27, 2026 | SESE | | [K253978](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K253978.md) | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | Feb 24, 2026 | SESE | | [K260185](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K260185.md) | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | Feb 18, 2026 | SESE | | [K260177](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K260177.md) | Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. | Feb 12, 2026 | SESE | | [K251923](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K251923.md) | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | Jan 29, 2026 | SESE | | [K252957](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K252957.md) | Pneumo Dissector Hook | Ab Medica Sas | Jan 23, 2026 | SESE | | [K254014](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K254014.md) | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Endoscopy | Jan 13, 2026 | SESE | | [K250927](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K250927.md) | KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG | Nov 22, 2025 | SESE | | [K242606](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K242606.md) | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | Nov 20, 2025 | SESE | | [K252442](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K252442.md) | Kii Structural Balloon Access System | Applied Medical Resources Corp. | Oct 31, 2025 | SESE | | [K252697](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K252697.md) | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. | Oct 29, 2025 | SESE | | [K252640](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K252640.md) | VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC | Oct 20, 2025 | SESE | | [K251994](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K251994.md) | Arthrex Synergy Vision Imaging System | Arthrex, Inc. | Oct 16, 2025 | SESE | | [K243968](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K243968.md) | Revolve Surgical System | Revolve Surgical, Inc. | Oct 3, 2025 | SESE | | [K250551](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K250551.md) | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | Shenzhen Sophway Technology Co., Ltd. | Oct 2, 2025 | SESE | | [K251743](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K251743.md) | SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | Surgical Principals, Inc. | Sep 22, 2025 | SESE | | [K250130](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K250130.md) | Viction 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.,Ltd | Aug 6, 2025 | SESE | | [K250124](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ/K250124.md) | Viction 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.,Ltd | Aug 6, 2025 | SESE | ## Top Applicants - KARL STORZ Endoscopy-America, Inc. — 47 clearances - Origin Medsystems, Inc. — 34 clearances - Phx Technologies Corp. — 33 clearances - United States Surgical, A Division of Tyco Healthc — 30 clearances - Richard Wolf Medical Instruments Corp. — 28 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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