Data / Medical devices / Endoscope Channel Accessory
Endoscope Channel Accessory (ODC): 50 FDA-registered makers in 11 countries
50 establishments in 11 countries are registered with the FDA to make Endoscope Channel Accessory (product code ODC, Class 2, 21 CFR 876.1500). 39 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 72 510(k) clearances under this code, the latest on June 12, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- ODC
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 19 |
| China | 15 |
| Japan | 5 |
| Ireland | 2 |
| Hong Kong | 2 |
| Germany | 2 |
| Israel | 1 |
| South Korea | 1 |
| Italy | 1 |
| Dominican Republic | 1 |
| Vietnam | 1 |
Makers of Endoscope Channel Accessory
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| United States Endoscopy Group, Inc. | Mentor, OH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 10 | October 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medivators Inc | Conroe, TX, United States | Manufacturer, Specification developer | 9 | November 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 5 | October 9, 2025 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 5 | October 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 5 | October 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ga Health Company Limited | Hong Kong, Hong Kong | Complaint file establishment, Exporter to the US, Specification developer | 4 | October 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Yangzhou Jiangsu, China | Manufacturer | 3 | June 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Johns Creek, GA, United States | Manufacturer | 2 | October 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 2 | March 27, 2001 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | CORK Munster, Ireland | Manufacturer | 2 | October 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 2 | November 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 2 | July 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 2 | July 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Smart Medical Systems Ltd. | Raanana Central, Israel | Manufacturer | 2 | February 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| The Ruhof Corporation | Mineola, NY, United States | Complaint file establishment, Manufacturer | 2 | October 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Wilson Instruments (sha) Co., Ltd. | Shanghai, China | Manufacturer | 2 | January 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Wilson-Cook Medical Inc. | Winston Salem, NC, United States | Complaint file establishment, Manufacturer | 2 | April 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 1 | March 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai, China | Complaint file establishment, Manufacturer | 1 | October 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 1 | March 18, 1992 | 0 | 0 | 0 | api.fda.gov |
| Anrei Medical (Hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Manufacturer | 1 | May 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 1 | March 18, 1992 | 0 | 0 | 0 | api.fda.gov |
| Dyne Medical Group Inc. | Gimpo- si Gyeonggi, South Korea | Manufacturer | 1 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Endosound Inc | Portland, OR, United States | Complaint file establishment, Manufacturer | 1 | October 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Endostart SRL | Certaldo Firenze, Italy | Manufacturer | 1 | March 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM medwork GmbH | Hochstadt/Aisch Bavaria, Germany | Manufacturer | 1 | September 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 1 | April 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | KURIHARA-SHI Miyagi, Japan | Exporter to the US, Manufacturer | 1 | December 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 1 | December 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer, Repackager or relabeler | 1 | December 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 1 | March 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 1 | March 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Seegen Photoelectric Technology Co., Ltd | Shanghai, China | Manufacturer | 1 | November 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Seegen Photoelectric Technology Co., Ltd | Shanghai, China | Manufacturer | 1 | November 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 1 | July 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| SML Med-Tech Solutions Limited | Hong Kong, Hong Kong | Manufacturer | 1 | January 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Manufacturer | 1 | January 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Manufacturer | 1 | January 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | December 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Dominican Republic Inc. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centerpoint Systems LLC | West Valley City, UT, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coopersurgical, Inc. | Trumbull, CT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ga Health Vietnam Company Limited | Ho Chi Minh Tay Ninh, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou City Zhejiang, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nolato Contour | Baldwin, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OBP Medical Corporation | Lawrence, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PMC SMART Solutions, LLC | Shelbyville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf Medical Instruments Corp. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smartdata Suzhou Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.