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Data / Medical devices / Endoscopic Access Overtube, Gastroenterology-Urology / United States

FDA-registered makers of Endoscopic Access Overtube, Gastroenterology-Urology in the United States: 32 establishments

32 establishments in the United States are registered with the FDA to make Endoscopic Access Overtube, Gastroenterology-Urology (product code FED). 20 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.

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Device
Endoscopic Access Overtube, Gastroenterology-Urology
Product code
FED
Country
United States

Makers of Endoscopic Access Overtube, Gastroenterology-Urology in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer4August 4, 2026010api.fda.gov
Neptune Medical, IncBurlingame, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer4June 27, 2024000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer3August 4, 2026000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer3August 4, 2026000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer3May 29, 2019000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer3May 29, 2019010api.fda.gov
Spirus Medical, LLCW Bridgewater, MA, United StatesSpecification developer3May 6, 2008000api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Manufacturer2May 23, 2003000api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer2May 23, 2003000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer2March 31, 2016000api.fda.gov
Dornier Medtech America, Inc.Kennesaw, GA, United StatesComplaint file establishment, Specification developer2January 31, 2025000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesSpecification developer1July 9, 1984000api.fda.gov
Calyxo, Inc.Pleasanton, CA, United StatesManufacturer1February 2, 2024000api.fda.gov
Conmed CorporationUtica, NY, United StatesManufacturer1June 10, 1994000api.fda.gov
Cook Medical LLCBloomington, IN, United StatesComplaint file establishment, Contract manufacturer1September 5, 2025000api.fda.gov
Calyxo, Inc.Pleasanton, CA, United StatesManufacturer1February 2, 2024011api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer1April 14, 2015000api.fda.gov
Prodeon Medical, Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer1October 7, 2025000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesManufacturer1June 10, 2004000api.fda.gov
Usgi MedicalSan Clemente, CA, United StatesManufacturer1September 13, 2007000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Aspero Medical, Inc.Westminster, CO, United StatesSpecification developer0000api.fda.gov
Biomerics FmiAthens, TX, United StatesContract manufacturer0000api.fda.gov
Cogentix Medical, Inc.Orangeburg, NY, United StatesManufacturer0000api.fda.gov
Cogentix Medical, Inc.Westborough, MA, United StatesManufacturer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.fda.gov
Gastro ConceptsAlbuquerque, NM, United StatesManufacturer0000api.fda.gov
Medeologix LLCSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Rose MedicalGrand Rapids, MI, United StatesContract manufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer0000api.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.