K232758 is an FDA 510(k) clearance for the Comatryx OTC. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Strukmyer Medical, LLC (Mesquite, US). The FDA issued a Cleared decision on December 1, 2023, 84 days after receiving the submission on September 8, 2023.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K232758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2023 |
| Decision Date | December 01, 2023 |
| Days to Decision | 84 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 | - |