Revi System— 510(k) K252391

Substantially Equivalent

Bluewind Medical , Ltd.

FDA 510(k) clearance K252391 for Revi System, Substantially Equivalent on 2025-12-12. Applicant: Bluewind Medical , Ltd..

Clearance details

Applicant: Bluewind Medical , Ltd.
Product code: Code QXM
Advisory panel: Gastroenterology, Urology
Date received: 2025-07-31
Decision date: 2025-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herzliya, IL

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