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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 the device name listed in this FDA 510(k) record. The listed applicant is Viveve Medical, Inc.. It received FDA 510(k) clearance on 2020-01-16 under 510(k) 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. The listed applicant is Viveve Medical, Inc.. The 510(k) number is K193611.

When did Viveve 2.0 System receive FDA 510(k) clearance?

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

Who is the listed applicant for Viveve 2.0 System?

The FDA 510(k) record lists Viveve Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Viveve 2.0 System?

The FDA product code for Viveve 2.0 System is GEI.

Other records listing Viveve Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212678Viveve System, Viveve 2.0 SystemK200472Viveve SystemK190422Viveve System 2.0

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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