K250115
- 510(k) number
- K250115
- Device name
- Hemastyl() Wound Dressing
- Applicant
- Rapid Nexus Nanotech Wound Solutions, Inc. CA · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2025-10-14
- Date received
- 2025-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250115.pdf
Official FDA record: K250115
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.