K223257 is an FDA 510(k) clearance for the Miro3D Wound Matrix. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Reprise Biomedical (Plymouth, US). The FDA issued a Cleared decision on November 21, 2022, 31 days after receiving the submission on October 21, 2022.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K223257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2022 |
| Decision Date | November 21, 2022 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN - Wound Dressing With Animal-derived Material(s) |
| Device Class | - |