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Data / Medical devices / Endoscopic Guidewire, Gastroenterology-Urology / United States

FDA-registered makers of Endoscopic Guidewire, Gastroenterology-Urology in the United States: 12 establishments

12 establishments in the United States are registered with the FDA to make Endoscopic Guidewire, Gastroenterology-Urology (product code OCY). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.

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Device
Endoscopic Guidewire, Gastroenterology-Urology
Product code
OCY
Country
United States

Makers of Endoscopic Guidewire, Gastroenterology-Urology in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Lake Region MedicalChaska, MN, United StatesManufacturer, Specification developer5September 19, 2014000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler3January 3, 2013000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Contract sterilizer, Manufacturer1October 27, 2008020api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer1October 27, 2008000api.fda.gov
Heraeus Medical Components, LLCSaint Paul, MN, United StatesComplaint file establishment, Specification developer1March 16, 2015000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer1June 5, 1990000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer0000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer0000api.fda.gov

Updated November 3, 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.