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Finesse

FDA UDI

Class II (US FDA UDI)

by Utah Medical Products, Inc.

Identity

Trade Name
FINESSE FDA UDI
Generic Name
Electrosurgical system generator FDA UDI
Device Name
Electrosurgical Generator with Integrated Smoke Evacuation System, 115 VAC FDA UDI
Model / Reference
Finesse II+, 115VAC FDA UDI
Description
Electrosurgical Generator with Integrated Smoke Evacuation System, 115 VAC FDA UDI

Identifiers

Catalog Number
FIN2-110 FDA UDI
Primary DI / UDI-DI
H671FIN21100 FDA UDI
510(k) Number
K123310 FDA UDI
FDA Product Code
GEI FDA UDI
HGI FDA UDI
GMDN Term
Electrosurgical system generator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
884.4120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical system generator

Finesse by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical system generator.

Cleared under the same submission

K123310 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Utah Medical Products, Inc.

Sources (1)

  • FDA UDI 24e4fec8-f38b-4eb9-824e-c1a669b7aa75 38 fields · synced Jun 9, 2026