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) → OCZ — Endoscopic Grasping/Cutting Instrument, Non-Powered # OCZ · Endoscopic Grasping/Cutting Instrument, Non-Powered _Gastroenterology, Urology · 21 CFR 876.1500 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ ## Overview - **Product Code:** OCZ - **Device Name:** Endoscopic Grasping/Cutting Instrument, Non-Powered - **Regulation:** [21 CFR 876.1500](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1500) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) - **3rd-party reviewable:** yes ## 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 73) Showing 20 most recent of 73 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242923](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K242923.md) | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) | Envision Endoscopy | Dec 20, 2024 | SESE | | [K191900](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K191900.md) | Single Use Grasping Forceps | Zhejiang Chuangxiang Medical Technology Co., Ltd. | Mar 27, 2020 | SESE | | [K152802](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K152802.md) | Grasping Forceps | Micro-Tech (Nanjing) Co., Ltd. | Jan 21, 2016 | SESE | | [K150939](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K150939.md) | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | Jun 8, 2015 | SESE | | [K141058](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K141058.md) | ENSIZOR ENDOSCOPIC SCISSORS | Slater Endoscopy, LLC | Aug 1, 2014 | SESE | | [K133736](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K133736.md) | ENDOSCOPIC SUTURE CUTTER | United States Endoscopy Group, Inc. | Jan 7, 2014 | SESE | | [K120084](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K120084.md) | ENDOSCOPIC RETRIEVAL DEVICE | United States Endoscopy Group, Inc. | May 30, 2012 | SESE | | [K103688](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K103688.md) | G-PROX EZ ENDOSCOPIC GRASPER | Usgi Medical | Jan 14, 2011 | SESE | | [K101298](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K101298.md) | ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS | Endochoice, Inc. | Aug 5, 2010 | SESE | | [K072684](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K072684.md) | MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM | Mondeal North America, Inc. | Jan 4, 2008 | SESE | | [K051276](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K051276.md) | HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM | Richard Wolf Medical Instruments Corp. | Oct 28, 2005 | SESE | | [K012074](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K012074.md) | XBO1-824-18/19/20 BIOPSY FORCEPS | The Olympus Optical Co. | Sep 25, 2001 | SESE | | [K010412](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K010412.md) | FLEXIBLE ENDOSCOPIC SCISSORS | Telemed Systems, Inc. | Apr 2, 2001 | SESE | | [K974300](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K974300.md) | TELEMED SYSTEMS RETRIEVAL BASKET | Telemed Systems, Inc. | Dec 19, 1997 | SESE | | [K973071](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K973071.md) | TRI TALON RETRIEVAL FORCEPS | Medical Engineering Laboratory, Inc. | Oct 24, 1997 | SESE | | [K973259](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K973259.md) | K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS) | Medical Creative Technologies, Inc. | Sep 10, 1997 | SESE | | [K971123](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K971123.md) | STONE EXTRACTOR | Phx Technologies Corp. | Jun 27, 1997 | SESE | | [K971202](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K971202.md) | COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS | Comeg Endoskopie GmbH | May 27, 1997 | SESE | | [K970982](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K970982.md) | T-RX RETRIEVAL FORCEPS | Tri-Med Specialties, Inc. | May 9, 1997 | SESE | | [K965176](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ/K965176.md) | PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS | Pilling Weck Group | Mar 4, 1997 | SESE | ## Top Applicants - Endovations — 14 clearances - Mr Associates, Inc. — 6 clearances - Olympus America, Inc. — 4 clearances - Hobbs Medical, Inc. — 3 clearances - Cook Urological, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/OCZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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