K201577 is an FDA 510(k) clearance for the MatriDerm. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Medskin Solutions Dr. Suwelack AG (Billerbeck, DE). The FDA issued a Cleared decision on January 7, 2021, 210 days after receiving the submission on June 11, 2020.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K201577 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2020 |
| Decision Date | January 07, 2021 |
| Days to Decision | 210 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 | - |