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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Viveve Medical, Inc.. It received FDA 510(k) clearance on 2021-09-14 under 510(k) 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. The listed applicant is Viveve Medical, Inc.. The 510(k) number is K212678.

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

Viveve System, Viveve 2.0 System received FDA 510(k) clearance on 2021-09-14, under 510(k) number K212678.

Who is the listed applicant for Viveve System, 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 System, Viveve 2.0 System?

The FDA product code for Viveve System, 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.

K200472Viveve SystemK193611Viveve 2.0 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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