K251323 is an FDA 510(k) clearance for the Device 104 Particulate. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Geistlich Pharma AG (Wolhusen, CH). The FDA issued a Cleared decision on January 22, 2026, 268 days after receiving the submission on April 29, 2025.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K251323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2025 |
| Decision Date | January 22, 2026 |
| Days to Decision | 268 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 | — |