Viveve System, Viveve 2.0 System
K-Number: K212678 · 2021-09-14
ApplicantViveve Medical, Inc.
Decision Date2021-09-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Viveve System, Viveve 2.0 System is a medical device manufactured by Viveve Medical, Inc.. It received FDA 510(k) clearance on 2021-09-14 under approval number K212678. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Viveve System, Viveve 2.0 System?
Viveve System, Viveve 2.0 System is a medical device that received FDA 510(k) clearance on 2021-09-14. It is manufactured by Viveve Medical, Inc.. The 510(k) number is K212678.
When was Viveve System, Viveve 2.0 System approved by the FDA?
Viveve System, Viveve 2.0 System received FDA 510(k) clearance on 2021-09-14, under approval number K212678.
What company makes Viveve System, Viveve 2.0 System?
Viveve System, Viveve 2.0 System is manufactured by Viveve Medical, Inc..
What is the FDA product code for Viveve System, Viveve 2.0 System?
The FDA product code for Viveve System, Viveve 2.0 System is GEI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.