FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)

Electrosurgical, Cutting & Coagulation & Accessories

UTAH MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Finesse 3rd Generation (models Finesse+ And Finesseii+).

Pre-market Notification Details

• Device ID: K123310
• 510k Number: K123310
• Device Name: FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: UTAH MEDICAL PRODUCTS, INC. 7043 South 300 West Midvale, UT 84047
• Contact: Ben Shirley
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2012-10-25
• Decision Date: 2013-01-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H671FIN8000	K123310	000
H671FIN22200	K123310	000
H671FIN2200	K123310	000
H671FIN21100	K123310	000
H671FIN1100	K123310	000