Vashe Plus Antimicrobial Solution— 510(k) K253665
Substantially EquivalentUrgo Medical North America, LLC
FDA 510(k) clearance K253665 for Vashe Plus Antimicrobial Solution, Substantially Equivalent on 2026-08-11. Applicant: Urgo Medical North America, LLC. Device class: Unclassified.
Summary
Urgo Medical North America's Vashe Plus Antimicrobial Solution is filed under product code FRO, drug wound dressings. The record gives no sizes or model numbers.
The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The General and Plastic Surgery review panel handled it as a Traditional 510(k).
Urgo filed from Fort Worth, Texas. The decision came 263 calendar days after FDA received it (November 21, 2025 to August 11, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Urgo Medical North America, LLC
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Recent devices under product code FRO
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.