K213498 is an FDA 510(k) clearance for the PELNAC Meshed Bilayer Wound Matrix. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Gunze Limited (Ayabe, Kyoto, JP). The FDA issued a Cleared decision on July 14, 2022, 255 days after receiving the submission on November 1, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K213498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2021 |
| Decision Date | July 14, 2022 |
| Days to Decision | 255 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 | - |