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Data / Medical devices / Endoscope, Ac-Powered And Accessories

Endoscope, Ac-Powered And Accessories (GCP): 13 FDA-registered makers in 5 countries

13 establishments in 5 countries are registered with the FDA to make Endoscope, Ac-Powered And Accessories (product code GCP, Class 2, 21 CFR 876.1500). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on April 10, 1996, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

CountryMakers
Germany9
Taiwan1
Czechia1
United Kingdom1
Italy1

Makers of Endoscope, Ac-Powered And Accessories

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
Med Contact GMBHBurladingen-Salmendingen Baden-Wurttemberg, GermanySpecification developer1April 2, 1979000api.fda.gov
North Eos Industries, Inc.Taichung City, TaiwanManufacturer1April 10, 1996000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Manufacturer, Specification developer1April 2, 1979000api.fda.gov
Olympus Medical Products CzechPrerov II Predmosti, CzechiaManufacturer1April 2, 1979000api.fda.gov
Bacher Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
BENTEC Endoscopy GmbHRietheim-Weilheim Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Bowa-Electronic GMBHGOMARINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Boyd Weiler GmbH & Co. KGWeiler-Simmerberg Bavaria, GermanyContract manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Haemoband Surgical LtdBelfast Northern Ireland, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Hermann Medizintechnik GMBHFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Josef Bacher GMBHRietheim-Weilheim Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
THD SPACorreggio Reggio Emilia, ItalyManufacturer0000api.fda.gov

Updated April 10, 1996. 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.