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Data / Medical devices / Urethrotome

Urethrotome (EZO): 20 FDA-registered makers in 4 countries

20 establishments in 4 countries are registered with the FDA to make Urethrotome (product code EZO, Class 2, 21 CFR 876.4770). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on May 12, 2000, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Get every maker of this deviceMakers in GermanyWatch this device
Product code
EZO
Device class
2
Regulation
876.4770
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
Germany14
United States4
Pakistan1
India1

Makers of Urethrotome

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
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer2February 13, 1995000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Manufacturer, Specification developer1January 7, 1992000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer1May 12, 2000000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Ackermann Instrumente GMBHRIETHEIM, WEILHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Gimmi GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Henke-Sass Wolf, GMBH.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Josef Bacher GMBHRietheim-Weilheim Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
National Advanced Endoscopy Devices, Inc.Canoga Park, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesSpecification developer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Teufel & Gerlach GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Uramix, Inc.E Lansdowne, PA, United StatesSpecification developer0000api.fda.gov

Updated May 12, 2000. 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.