FET · Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | FET |
|---|---|
| Device Name | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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 98)
Showing 20 most recent of 98 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251734 | ProVee Video Processing Unit (PV-003) | Proverum Limited | Sep 24, 2025 | SESE |
| K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | Univlabs Technologies Private Limited | Aug 11, 2025 | SESE |
| K250204 | Endoscopic Camera System | Shenzhen Sophway Technology Co., Ltd. | Jul 1, 2025 | SESE |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Fujifilm Corporation | Apr 11, 2025 | SESE |
| K242067 | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | Olympus Corporations of the Americas | Apr 2, 2025 | SESE |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. | Feb 7, 2025 | SESE |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | Oct 22, 2024 | SESE |
| K241371 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation | Jul 3, 2024 | SESE |
| K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 | Olympus Medical Systems Corporation | Apr 26, 2023 | SESE |
| K212808 | Logic Hd camera head green, System green | Richard Wolf Medical Instruments Corporation | Jun 14, 2022 | SESE |
| K221174 | Telepack + | Karl Storz Endoscopy America, Inc. | May 13, 2022 | SESE |
| K211332 | D Camera Controller | Richard Wolf Medical Instruments Corporation | Oct 1, 2021 | SESE |
| K202646 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | Oct 29, 2020 | SESE |
| K201135 | Image1 S CCU, Image1 S 4U Camera Head | KARL STORZ Endoscopy-America, Inc. | Sep 1, 2020 | SESE |
| K201200 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | Jul 22, 2020 | SESE |
| K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 | Richard Wolf Medical Instruments Corporation | Jun 23, 2020 | SESE |
| K192286 | FUJIFILM EP-6000 Video Processor | Fujifilm Corporation | May 1, 2020 | SESE |
| K193235 | Telepack + | Karl Storz Endoscopy America, Inc. | Dec 20, 2019 | SESE |
| K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head | Olympus Medical Systems Corp. | Aug 30, 2019 | SESE |
| K190648 | Pusen Eview Medical Video Endoscope Image Processor | Zhuhai Pusen Medical Technology Co., Ltd. | Mar 29, 2019 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 10 clearances
- Richard Wolf Medical Instruments Corporation — 5 clearances
- Karl Storz Imaging, Inc. — 5 clearances
- Olympus Medical Systems Corporation — 4 clearances
- Olympus Medical Systems Corp. — 4 clearances
