# K191324: CivaDerm

- Pathway: 510(k) (Traditional)
- Applicant: Civatech Oncology, Inc.
- Decided: Sep 20, 2019 after 127 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931393 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090321: Ric Conformal Source, Model 100, Ri Consultants, LLC (2009) Summary page 4.

## Indications for use
CivaDermPd103 indicated for treatment of temporary intraoperative or surface application to treat selected localized tumors. It can be used either as primary treatment or as treatment for residual disease after excision of primary or recurrent tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy.

Source page: https://510kreport.com/device/K191324
Methodology: https://510kreport.com/methodology