K242828 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 October 18, 2024, 29 days after receiving the submission on September 19, 2024. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K242828 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 2024 |
| Decision Date | October 18, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN — Wound Dressing With Animal-derived Material(s) |
| Device Class | — |