K220317 is an FDA 510(k) clearance for the PuraPly Micronized Wound Matrix (PuraPly MZ). This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Organogenesis, Inc. (Canton, US). The FDA issued a Cleared decision on July 1, 2022, 148 days after receiving the submission on February 3, 2022.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K220317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2022 |
| Decision Date | July 01, 2022 |
| Days to Decision | 148 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 | - |