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.
Clearance details
- Applicant
- Bluewind Medical , Ltd.
- Product code
- 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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