K213341 is an FDA 510(k) clearance for the Fibrillar Collagen Wound Dressing. 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 May 31, 2022, 236 days after receiving the submission on October 7, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K213341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2021 |
| Decision Date | May 31, 2022 |
| Days to Decision | 236 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 | — |