K191324 is an FDA 510(k) clearance for the CivaDerm. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Civatech Oncology, Inc. (Durham, US). The FDA issued a Cleared decision on September 20, 2019, 127 days after receiving the submission on May 16, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K191324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2019 |
| Decision Date | September 20, 2019 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KXK - Source, Brachytherapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |