K231325 is an FDA 510(k) clearance for the Corplex P / Theracor P / Allacor P, a Wound Dressing With Animal-derived Material(s), submitted by Stimlabs, LLC (Roswell, US). The FDA issued a Cleared decision on February 2, 2024, 270 days after receiving the submission on May 8, 2023. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K231325 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 08, 2023 |
| Decision Date | February 02, 2024 |
| Days to Decision | 270 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 | — |