K242985 is an FDA 510(k) clearance for the CollOvine? Wound Dressing, a Wound Dressing With Animal-derived Material(s), submitted by Ovigenex, LLC (Dominguez Hills, US). The FDA issued a Cleared decision on June 20, 2025, 267 days after receiving the submission on September 26, 2024. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K242985 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2024 |
| Decision Date | June 20, 2025 |
| Days to Decision | 267 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 | — |