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

Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) (KNF): 29 FDA-registered makers in 7 countries

29 establishments in 7 countries are registered with the FDA to make Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) (product code KNF, Class 2, 21 CFR 884.4160). 13 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 45 510(k) clearances under this code, the latest on September 24, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
KNF
Device class
2
Regulation
884.4160
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
United States14
Germany10
Switzerland1
Denmark1
Mexico1
United Kingdom1
Poland1

Makers of Coagulator-Cutter, Endoscopic, Unipolar (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
Gynesonics, Inc.Redwood City, CA, United StatesManufacturer4April 2, 2025000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer3September 24, 2026000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer2February 8, 2012000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer1June 11, 2001000api.fda.gov
Atc Technologies Inc.Wilmington, MA, United StatesManufacturer1June 14, 2013000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer1February 22, 1994000api.fda.gov
ConMed CorporationGreenwood Village, CO, United StatesSpecification developer1February 22, 1994000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer1February 28, 1994000api.fda.gov
LiNA Medical AGRoot D4 Luzern, SwitzerlandExporter to the US, Manufacturer1October 30, 2007000api.fda.gov
LiNA Medical ApSNaerum Hovedstaden, DenmarkSpecification developer1October 30, 2007000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer1April 10, 1998000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer1July 10, 1998000api.fda.gov
Zinnanti Surgical Design Group IncSanta Cruz, CA, United StatesSpecification developer1February 28, 1994000api.fda.gov
Apical InstrumentsRedwood City, CA, United StatesContract manufacturer0000api.fda.gov
Centerpiece S. De R.L De C.VPlayas de Rosarito Baja California, MexicoContract manufacturer0000api.fda.gov
Guenter Bissinger Medizintechnik GMBHTENINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Gyrus Medical Ltd.CARDIFF Wales, United KingdomContract 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
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
Koscher & Wuertz GMBHSPAICHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
LiNA Medical Polska sp. z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Modo IncHillsboro, OR, United StatesContract manufacturer0000api.fda.gov
Modo Inc.Tualatin, OR, United StatesContract manufacturer0000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov

Updated September 24, 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.