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FDA 510(k)

Viveve System

K-Number: K162547 · 2016-10-06

ApplicantViveve, Inc.
Decision Date2016-10-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Viveve System is the device name listed in this FDA 510(k) record. The listed applicant is Viveve, Inc.. It received FDA 510(k) clearance on 2016-10-06 under 510(k) number K162547. 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 System is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is Viveve, Inc.. The 510(k) number is K162547.

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

Viveve System received FDA 510(k) clearance on 2016-10-06, under 510(k) number K162547.

Who is the listed applicant for Viveve System?

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

What is the FDA product code for Viveve System?

The FDA product code for Viveve System is GEI.

Other records listing Viveve, 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.

K213814Viveve 2.0 SystemK180584Viveve RF System, Secure

Related Devices (Code: GEI)

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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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