K253665
- 510(k) number
- K253665
- Device name
- Vashe Plus Antimicrobial Solution
- Applicant
- Urgo Medical North America, LLC TX · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2026-08-11
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253665.pdf
Official FDA record: K253665
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.