Viveve 2.0 System

Electrosurgical, Cutting & Coagulation & Accessories

Viveve Medical, Inc.

The following data is part of a premarket notification filed by Viveve Medical, Inc. with the FDA for Viveve 2.0 System.

Pre-market Notification Details

Device IDK193611
510k NumberK193611
Device Name:Viveve 2.0 System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Viveve Medical, Inc. 345 Inverness Drive South, Building B, Suite 250 Englewood,  CO  80112
ContactKevin Robison
CorrespondentKevin Robison
Viveve Medical, Inc. 345 Inverness Drive South, Building B, Suite 250 Englewood,  CO  80112
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2020-01-16

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