K253651
- 510(k) number
- K253651
- Device name
- Revi System
- Applicant
- Bluewind Medical , Ltd. IL
- Product code
- QXM — Implanted Tibial Electrical Urinary Continence Devic
- Decision date
- 2026-07-28
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K253651.pdf
Official FDA record: K253651
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.