K243071 is an FDA 510(k) clearance for the Bovine Dermis Collagen Dermal Matrix. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on December 19, 2024, 83 days after receiving the submission on September 27, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K243071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2024 |
| Decision Date | December 19, 2024 |
| Days to Decision | 83 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 | — |