Clearance Summary
Vashe Plus Antimicrobial Solution received FDA 510(k) clearance under submission number K253665, sponsored by Urgo Medical North America, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2026-08-11.
- Submission: K253665
- Applicant / Sponsor: Urgo Medical North America, LLC
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2026-08-11
Classification & Regulation
This clearance is catalogued under FDA product code FRO , within the Unknown review panel as a device.