510(k) K253665 ยท FRO Dressing, Wound, Drug
Vashe Plus Antimicrobial Solution
| Applicant | Urgo Medical North America, LLC, Fort Worth TX, US |
| Decision | Substantially Equivalent, Aug 11, 2026 |
| Received | Nov 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253665
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.