FDA 510(k)

CivaDerm

K-Number: K191324 · 2019-09-20

Decision Date2019-09-20

Product CodeKXK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CivaDerm is the device name listed in this FDA 510(k) record. The listed applicant is Civatech Oncology, Inc.. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K191324. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CivaDerm?

CivaDerm is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Civatech Oncology, Inc.. The 510(k) number is K191324.

When did CivaDerm receive FDA 510(k) clearance?

CivaDerm received FDA 510(k) clearance on 2019-09-20, under 510(k) number K191324.

Who is the listed applicant for CivaDerm?

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

What is the FDA product code for CivaDerm?

The FDA product code for CivaDerm is KXK.

Related Devices (Code: KXK)

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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.