Clearance Summary
Revi System received FDA 510(k) clearance under submission number K252391, sponsored by Bluewind Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-12-12.
- Submission: K252391
- Applicant / Sponsor: Bluewind Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5305
- Decision date: 2025-12-12
Classification & Regulation
This clearance is catalogued under FDA product code QXM and 21 CFR 876.5305, within the Gastroenterology, Urology review panel as a Class II device.