Data / Medical devices / Coagulator, Laparoscopic, Unipolar (And Accessories)
Coagulator, Laparoscopic, Unipolar (And Accessories) (HFG): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Coagulator, Laparoscopic, Unipolar (And Accessories) (product code HFG, Class 2, 21 CFR 884.4160). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on September 28, 2018, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HFG
- Device class
- 2
- Regulation
- 884.4160
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 1 |
| United Kingdom | 1 |
| Germany | 1 |
Makers of Coagulator, Laparoscopic, 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 |
|---|---|---|---|---|---|---|---|---|
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 1 | February 19, 1991 | 0 | 0 | 0 | api.fda.gov |
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 1 | February 19, 1991 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | September 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Marlborough, MA, United States | Manufacturer | 1 | September 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| ATL Technology DG,Ltd. | Dongguan Guangdong, China | 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 | |
| Olympus Winter & Ibe GMBH | Hamburg, Germany | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 28, 2018. 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.