K210949 is an FDA 510(k) clearance for the Foundation Dermal Regeneration Scaffold (DRS) Solo. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Bionova Medical, Inc. (Germantown, US). The FDA issued a Cleared decision on August 11, 2022, 499 days after receiving the submission on March 30, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K210949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2021 |
| Decision Date | August 11, 2022 |
| Days to Decision | 499 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN - Wound Dressing With Animal-derived Material(s) |
| Device Class | - |