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FDA 510(k)

Viveve System 2.0

K-Number: K190422 · 2019-06-12

ApplicantViveve Medical
Decision Date2019-06-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Viveve System 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Viveve Medical. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K190422. 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 2.0?

Viveve System 2.0 is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is Viveve Medical. The 510(k) number is K190422.

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

Viveve System 2.0 received FDA 510(k) clearance on 2019-06-12, under 510(k) number K190422.

Who is the listed applicant for Viveve System 2.0?

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

What is the FDA product code for Viveve System 2.0?

The FDA product code for Viveve System 2.0 is GEI.

Other records listing Viveve Medical 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 SystemK193611Viveve 2.0 System

Related Devices (Code: GEI)

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.

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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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