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) → OCW — Endoscopic Tissue Approximation Device # OCW · Endoscopic Tissue Approximation Device _Gastroenterology, Urology · 21 CFR 876.1500 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW ## Overview - **Product Code:** OCW - **Device Name:** Endoscopic Tissue Approximation Device - **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 70) Showing 20 most recent of 70 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252400](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K252400.md) | Endomina EZFuse system | Endo Tools Therapeutics S.A. | Feb 13, 2026 | SESE | | [K243750](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K243750.md) | SimpleStitch Suturing System | Envision Endoscopy | Apr 17, 2025 | SESE | | [K231240](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K231240.md) | MaxTack™ Motorized Fixation Device | Covidien | Sep 8, 2023 | SESE | | [K213271](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K213271.md) | MedicloseTM System | Health Value Creation B.V., Trading AS Corporis Medical | Aug 31, 2023 | SESE | | [K231553](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K231553.md) | OverStitch NXT Endoscopic Suturing System | Apollo Endosurgery, Inc. | Jun 29, 2023 | SESE | | [K211309](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K211309.md) | endomina system | Endo Tools Therapeutics S.A. | Dec 7, 2021 | SESE | | [K201744](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K201744.md) | Su2ura Approximation Device | Anchora Medical, Ltd. | Jun 17, 2021 | SESE | | [K210266](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K210266.md) | OverStitch Sx Endoscopic Suturing System | Apollo Endosurgery, Inc. | Mar 2, 2021 | SESE | | [K193652](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K193652.md) | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | Mar 26, 2020 | SESE | | [K191439](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K191439.md) | OverStitch 2-0 Polypropylene Suture | Apollo Endosurgery | Aug 29, 2019 | SESE | | [K181141](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K181141.md) | OverStitch Endoscopic Suturing System and Accessories | Apollo Endosurgery | Jun 27, 2018 | SESE | | [K172775](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K172775.md) | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | Feb 12, 2018 | SESE | | [K172666](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K172666.md) | CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor | Sutureease, Inc. | Dec 1, 2017 | SESE | | [K171886](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K171886.md) | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | Nov 15, 2017 | SESE | | [K160117](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K160117.md) | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | Sep 9, 2016 | SESE | | [K160149](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K160149.md) | Miret Grasper, Alligator, Miret Grasper, Maryland | Miret Surgical, Inc. | Aug 30, 2016 | SESE | | [K132232](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K132232.md) | MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM | Minilap Technologies | Dec 4, 2013 | SESE | | [K132362](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K132362.md) | WECK EFX ENDO FASCIAL CLOSURE SYSTEM | Teleflexmedical, Inc. | Oct 8, 2013 | SESE | | [K120147](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K120147.md) | ACE STAPLER AND CARTRIDGE | Barosense, Inc. | Feb 17, 2012 | SESE | | [K110829](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW/K110829.md) | ACE STAPLER AND CARTRIDGE | Barosense, Inc. | Jun 3, 2011 | SESE | ## Top Applicants - Ethicon Endo-Surgery, Inc. — 10 clearances - Apollo Endosurgery, Inc. — 4 clearances - Opus Medical, Inc. — 4 clearances - Barosense, Inc. — 3 clearances - Endogastric Solutions, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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