K213231 is an FDA 510(k) clearance for the Kerecis Silicone. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on June 29, 2022, 272 days after receiving the submission on September 30, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K213231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2021 |
| Decision Date | June 29, 2022 |
| Days to Decision | 272 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 | - |