FDA 510(k)

CivaDerm

K-Number: K191324 · 2019-09-20

Decision Date2019-09-20

Product CodeKXK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CivaDerm is a medical device manufactured by Civatech Oncology, Inc.. It received FDA 510(k) clearance on 2019-09-20 under approval 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. It is manufactured by Civatech Oncology, Inc.. The 510(k) number is K191324.

When was CivaDerm approved by the FDA?

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

What company makes CivaDerm?

CivaDerm is manufactured by Civatech Oncology, Inc..

What is the FDA product code for CivaDerm?

The FDA product code for CivaDerm is KXK.

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Official Source

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