FINESSE Starter Kit
by Utah Medical Products, Inc.
FINESSE Starter Kit (FIN-800) is a Class II device made by Utah Medical Products, Inc., cleared under FDA 510(k) K123310 on 23 Jan 2013 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI H671FIN8000), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberH671FIN8000 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK123310 | Date23 Jan 2013 | StatusActive |
Official records
- FDA 510(k) database K123310
Across registries
- FDA 510(k) K123310 decided 23 Jan 2013 Active
- FDA GUDID UDI-DI H671FIN8000 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K123310
- Listed FDA GUDID H671FIN8000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Finesse
- Generic name
- Electrosurgical system generator
- Model / Ref / Catalog
- Starter Kit, FIN-800
- Primary DI / UDI-DI
- H671FIN8000
- 510(k) Number
- FDA product code
- GEI, HGI
- GMDN term
- Electrosurgical system generator
- Device class
- Class II
- Regulation number
- 878.4400, 884.4120
- GUDID distribution status
- In Commercial Distribution
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