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
| Country | Makers |
|---|---|
| United States | 14 |
| Germany | 10 |
| Switzerland | 1 |
| Denmark | 1 |
| Mexico | 1 |
| United Kingdom | 1 |
| Poland | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gynesonics, Inc. | Redwood City, CA, United States | Manufacturer | 4 | April 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 3 | September 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 2 | February 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 1 | June 11, 2001 | 0 | 0 | 0 | api.fda.gov |
| Atc Technologies Inc. | Wilmington, MA, United States | Manufacturer | 1 | June 14, 2013 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 1 | February 22, 1994 | 0 | 0 | 0 | api.fda.gov |
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 1 | February 22, 1994 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Manufacturer | 1 | February 28, 1994 | 0 | 0 | 0 | api.fda.gov |
| LiNA Medical AG | Root D4 Luzern, Switzerland | Exporter to the US, Manufacturer | 1 | October 30, 2007 | 0 | 0 | 0 | api.fda.gov |
| LiNA Medical ApS | Naerum Hovedstaden, Denmark | Specification developer | 1 | October 30, 2007 | 0 | 0 | 0 | api.fda.gov |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | April 10, 1998 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Specification developer | 1 | July 10, 1998 | 0 | 0 | 0 | api.fda.gov |
| Zinnanti Surgical Design Group Inc | Santa Cruz, CA, United States | Specification developer | 1 | February 28, 1994 | 0 | 0 | 0 | api.fda.gov |
| Apical Instruments | Redwood City, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centerpiece S. De R.L De C.V | Playas de Rosarito Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guenter Bissinger Medizintechnik GMBH | TENINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gyrus Medical Ltd. | CARDIFF Wales, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koscher & Wuertz GMBH | SPAICHINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LiNA Medical Polska sp. z o.o | Tarnowo Podgorne Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo Inc | Hillsboro, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo Inc. | Tualatin, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olympus Winter & Ibe GMBH | Hamburg, Germany | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tontarra Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.