CivaDerm

FDA 510(k) K191324 · Civatech Oncology, Inc.

Substantially Equivalent

510(k) numberK191324

Submission

Device name
CivaDerm
Applicant
Civatech Oncology, Inc.
Durham, NC, US
Received
May 16, 2019
Decision date
September 20, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXK – Source, Brachytherapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Specialty
Radiology
Implant
Yes

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Questions and answers

When was CivaDerm cleared by the FDA?

CivaDerm (K191324) received a 510(k) decision of Substantially Equivalent on September 20, 2019, 127 days after the submission was received.

What is the product code of K191324?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.