Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Viveve 2.0 System

K-Number: K193611 · 2020-01-16

ApplicantViveve Medical, Inc.
Decision Date2020-01-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Viveve 2.0 System is a medical device manufactured by Viveve Medical, Inc.. It received FDA 510(k) clearance on 2020-01-16 under approval number K193611. 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 2.0 System?

Viveve 2.0 System is a medical device that received FDA 510(k) clearance on 2020-01-16. It is manufactured by Viveve Medical, Inc.. The 510(k) number is K193611.

When was Viveve 2.0 System approved by the FDA?

Viveve 2.0 System received FDA 510(k) clearance on 2020-01-16, under approval number K193611.

What company makes Viveve 2.0 System?

Viveve 2.0 System is manufactured by Viveve Medical, Inc..

What is the FDA product code for Viveve 2.0 System?

The FDA product code for Viveve 2.0 System is GEI.

Other Devices by Viveve Medical, Inc.

K200472Viveve System K212678Viveve System, Viveve 2.0 System

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑