K200502 is an FDA 510(k) clearance for the Myriad Particles. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Aroa Biosurgery , Ltd. (Mangere, NZ). The FDA issued a Cleared decision on March 31, 2021, 397 days after receiving the submission on February 28, 2020.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K200502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2020 |
| Decision Date | March 31, 2021 |
| Days to Decision | 397 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 | - |