K250397
- 510(k) number
- K250397
- Device name
- Helios Dermal Scaffold
- Applicant
- Helios Biomedical, Inc. MA · US
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2025-08-15
- Date received
- 2025-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250397.pdf
Official FDA record: K250397
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.