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Data / Medical devices / Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)

Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) (HIN): 17 FDA-registered makers in 7 countries

17 establishments in 7 countries are registered with the FDA to make Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) (product code HIN, Class 2, 21 CFR 884.4150). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on November 21, 2014, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
HIN
Device class
2
Regulation
884.4150
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
United States6
Germany6
Switzerland1
Denmark1
United Kingdom1
Mexico1
Poland1

Makers of Coagulator-Cutter, Endoscopic, Bipolar (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
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer2November 21, 2014000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Specification developer2November 21, 2014000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer1June 29, 2012000api.fda.gov
Elmed, Inc.Glendale Heights, IL, United StatesManufacturer1November 15, 1994000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer1June 26, 2013000api.fda.gov
LiNA Medical AGRoot D4 Luzern, SwitzerlandExporter to the US, Manufacturer1July 24, 2013000api.fda.gov
LiNA Medical ApSNaerum Hovedstaden, DenmarkSpecification developer1July 24, 2013000api.fda.gov
Olympus Winter & Ibe GmbHTELTOW Brandenburg, GermanySpecification developer1December 2, 2011000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer1April 16, 1999000api.fda.gov
Grace Manufacturing IncRussellville, AR, United StatesManufacturer0000api.fda.gov
Gyrus Medical Ltd.CARDIFF Wales, United KingdomContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract 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
LiNA Medical Polska sp. z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Richard Wolf Medical Instruments Corp.Vernon Hills, IL, United StatesContract manufacturer0000api.fda.gov

Updated November 21, 2014. 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.