K243181 is an FDA 510(k) clearance for the Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo. This device is classified as a Dressing, Wound, Drug.
Submitted by Bionova Medical, Inc. (Germantown, US). The FDA issued a Cleared decision on October 31, 2024, 31 days after receiving the submission on September 30, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K243181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | October 31, 2024 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |