510(k) K253665

Vashe Plus Antimicrobial Solution by Urgo Medical North America, LLC — Product Code FRO

K253665 is an FDA 510(k) premarket notification submitted by Urgo Medical North America, LLC for the device "Vashe Plus Antimicrobial Solution". The FDA issued a decision of Substantially Equivalent on August 11, 2026. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.