K250397 is an FDA 510(k) clearance for the Helios Dermal Scaffold. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Helios Biomedical, Inc. (Weston, US). The FDA issued a Cleared decision on August 15, 2025, 184 days after receiving the submission on February 12, 2025.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K250397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2025 |
| Decision Date | August 15, 2025 |
| Days to Decision | 184 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 | — |