K230980 is an FDA 510(k) clearance for the MicroMatrix® Flex. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on September 22, 2023, 170 days after receiving the submission on April 5, 2023.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K230980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2023 |
| Decision Date | September 22, 2023 |
| Days to Decision | 170 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 | — |