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Data / Medical devices / Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula (ODD): 12 FDA-registered makers in 5 countries

12 establishments in 5 countries are registered with the FDA to make Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula (product code ODD, Class 2, 21 CFR 876.1500). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on May 27, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
ODD
Device class
2
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States6
Japan2
Mexico2
Costa Rica1
Ireland1

Makers of Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

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
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JapanManufacturer3May 27, 2025000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer3May 27, 2025000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer2April 27, 1995000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesComplaint file establishment, Manufacturer2November 6, 2020000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer1November 28, 1983000api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer1November 28, 1983000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer1November 28, 1983000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer1November 28, 1983000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer1April 9, 1982000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer1March 20, 2018000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.fda.gov
Venusa de Mexico S. de R.L de C.VCIUDAD JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov

Updated May 27, 2025. 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.