ODC · Endoscope Channel Accessory
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | ODC |
|---|---|
| Device Name | Endoscope Channel Accessory |
| 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 71)
Showing 20 most recent of 71 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250145 | Biopsy Port Adapter | Endosound, Inc. | Oct 17, 2025 | SESE |
| K252910 | Orca Air/Water and Suction Valves | Boston Scientific | Oct 9, 2025 | SESK |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | Olympus Medical Systems Corporation | Jul 16, 2025 | SESE |
| K250732 | Disposable Endoscopy Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Jun 20, 2025 | SESE |
| K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corporation | Mar 19, 2025 | SESE |
| K250140 | Defendo Fujifilm 700 Single Use Cleaning Adapter | Steris Corparation | Feb 20, 2025 | SESE |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) | STERIS Corporation | Nov 8, 2024 | SESE |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | Oct 11, 2024 | SESE |
| K241285 | Disposable Endoscope Valves Set (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | Oct 1, 2024 | SESE |
| K232067 | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector | Medivators (A Subsidiary of Steris Corporation) | Mar 22, 2024 | SESE |
| K232327 | Endorail | Endostart S.R.L. | Mar 15, 2024 | SESE |
| K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | STERIS Corporation | Mar 6, 2024 | SESE |
| K232004 | Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector | Medivators (A Subsidiary of Steris Corporation) | Mar 6, 2024 | SESE |
| K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | Feb 9, 2024 | SESE |
| K232329 | Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter | Medivators (A Subsidiary of Steris Corporation) | Dec 21, 2023 | SESE |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | Pentax of America, Inc. | Dec 1, 2023 | SESE |
| K232244 | Disposable Endoscope Valves System | Changzhou Endoclean Medical Device Co., Ltd. | Nov 29, 2023 | SESE |
| K222499 | Disposable Endoscope Valves Kit | Shanghai SeeGen Photoelectric Technology Co., Ltd. | Nov 22, 2023 | SESE |
| K232951 | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) | Steris | Oct 20, 2023 | SESE |
| K232118 | ANDORATE® Valve Kit | Ga Health Company Limited | Oct 16, 2023 | SESE |
Top Applicants
- STERIS Corporation — 6 clearances
- Ga Health Company Limited — 4 clearances
- Yangzhou Fartley Medical Instrument Technology Co., Ltd. — 3 clearances
- United States Endoscopy Group, Inc. — 3 clearances
- Smart Medical Systems , Ltd. — 3 clearances
