K212766 is an FDA 510(k) clearance for the Maxiocel Chitosan Wound Dressing. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Advamedica, Inc. (Cambridge, US). The FDA issued a Cleared decision on August 24, 2023, 723 days after receiving the submission on August 31, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K212766 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2021 |
| Decision Date | August 24, 2023 |
| Days to Decision | 723 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 | - |