Finesse 3RD Generation (Models Finesse+ and FinesseII+)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123310 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Finesse 3rd Generation (Models Finesse+ and FinesseII+) is a loop electrosurgical excision procedure (LEEP) generator, classified under product code GEI. This device combines an electrosurgical generator with a smoke evacuation system into a single unit, designed for precise tissue excision and histopathology specimen preparation during gynecological procedures.
The system is intended for use in clinical settings, including office-based operating rooms with limited space. It is supplied as a reusable device and does not require sterilization between uses. The Finesse 3rd Generation has received FDA 510(k) clearance under the Traditional 510(k) review pathway and complies with the Medical Device Directive (MDD). No specific MRI safety or single-use indications are stated in the provided data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Finesse 3rd Generation (Models Finesse+ and Finesseii+), LEEP Surgery Electrosurgical Generator - Finesse - Utah Med, PDF Brochure, Finesse+/Finesse II+ - utahmed.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K123310 | Class II | Active |
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Manufacturer
- Manufacturer
- Utah Medical Products, Inc.
Sources (2)
- FDA 510(k) K123310 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 19, 2026