Revi System— 510(k) K253651
Substantially EquivalentBluewind Medical , Ltd.
FDA 510(k) clearance K253651 for Revi System, Substantially Equivalent on 2026-07-28. Applicant: Bluewind Medical , Ltd.. Device class: 2.
Summary
Bluewind Medical's Revi System is filed under QXM, implanted tibial electrical urinary continence devices. The record doesn't list the system's components.
Class II, 21 CFR 876.5305. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Bluewind Medical filed from Herzliya, Israel. The decision came 250 calendar days after FDA received it (November 20, 2025 to July 28, 2026).
Clearance details
- Applicant
- Bluewind Medical , Ltd.
- Product code
- Product code QXM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5305
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Herzliya, IL
Recent devices under product code QXM
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