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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

CountryMakers
United States19
China15
Japan5
Ireland2
Hong Kong2
Germany2
Israel1
South Korea1
Italy1
Dominican Republic1
Vietnam1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
United States Endoscopy Group, Inc.Mentor, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer10October 11, 2024000api.fda.gov
Medivators IncConroe, TX, United StatesManufacturer, Specification developer9November 8, 2024000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer5October 9, 2025010api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer5October 9, 2025000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer5October 9, 2025000api.fda.gov
Ga Health Company LimitedHong Kong, Hong KongComplaint file establishment, Exporter to the US, Specification developer4October 16, 2023000api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaManufacturer3June 20, 2025000api.fda.gov
Boston Scientific CorporationJohns Creek, GA, United StatesManufacturer2October 9, 2025000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer2March 27, 2001000api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer2October 9, 2025000api.fda.gov
Changzhou Endoclean Medical Device Co., Ltd.Changzhou Jiangsu, ChinaManufacturer2November 29, 2023000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer2July 26, 2018000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer2July 16, 2025000api.fda.gov
Smart Medical Systems Ltd.Raanana Central, IsraelManufacturer2February 6, 2012000api.fda.gov
The Ruhof CorporationMineola, NY, United StatesComplaint file establishment, Manufacturer2October 16, 2023000api.fda.gov
Wilson Instruments (sha) Co., Ltd.Shanghai, ChinaManufacturer2January 6, 2021000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer2April 26, 2022000api.fda.gov
Aizu Olympus Co., Ltd.AIZUWAKAMATSU-SHI Fukushima, JapanManufacturer1March 19, 2025000api.fda.gov
Alton Shanghai Medical Instruments Co LtdShanghai, ChinaComplaint file establishment, Manufacturer1October 1, 2024000api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer1March 18, 1992000api.fda.gov
Anrei Medical (Hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer1May 14, 2020000api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer1March 18, 1992000api.fda.gov
Dyne Medical Group Inc.Gimpo- si Gyeonggi, South KoreaManufacturer1June 12, 2026000api.fda.gov
Endosound IncPortland, OR, United StatesComplaint file establishment, Manufacturer1October 17, 2025000api.fda.gov
Endostart SRLCertaldo Firenze, ItalyManufacturer1March 15, 2024000api.fda.gov
FUJIFILM medwork GmbHHochstadt/Aisch Bavaria, GermanyManufacturer1September 10, 2021000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer1April 4, 2019000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionKURIHARA-SHI Miyagi, JapanExporter to the US, Manufacturer1December 1, 2023000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionAkishima-shi Tokyo, JapanComplaint file establishment, Specification developer1December 1, 2023000api.fda.gov
Hangzhou AGS MedTech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer, Repackager or relabeler1December 23, 2020000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer1March 29, 2022000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer1March 29, 2022000api.fda.gov
Shanghai Seegen Photoelectric Technology Co., LtdShanghai, ChinaManufacturer1November 22, 2023000api.fda.gov
Shanghai Seegen Photoelectric Technology Co., LtdShanghai, ChinaManufacturer1November 22, 2023000api.fda.gov
Shirakawa Olympus Co., Ltd.NISHISHIRAKAWA-GUN Fukushima, JapanManufacturer1July 16, 2025000api.fda.gov
SML Med-Tech Solutions LimitedHong Kong, Hong KongManufacturer1January 17, 2023000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaManufacturer1January 14, 2022000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaManufacturer1January 14, 2022000api.fda.gov
Zhejiang Chuangxiang Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer, Repackager or relabeler1December 30, 2019000api.fda.gov
B. Braun Dominican Republic Inc.SANTO DOMINGO Distrito Nacional, Dominican RepublicContract manufacturer0000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ga Health Vietnam Company LimitedHo Chi Minh Tay Ninh, VietnamContract manufacturer0000api.fda.gov
Hangzhou Fushan Medical Appliance Co., Ltd.Hangzhou City Zhejiang, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Nolato ContourBaldwin, WI, United StatesContract manufacturer0000api.fda.gov
OBP Medical CorporationLawrence, MA, United StatesSpecification developer0000api.fda.gov
PMC SMART Solutions, LLCShelbyville, IN, United StatesContract manufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Richard Wolf Medical Instruments Corp.Vernon Hills, IL, United StatesContract manufacturer0000api.fda.gov
Smartdata Suzhou Co., LtdSuzhou Jiangsu, ChinaContract manufacturer0000api.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.