K240037
- 510(k) number
- K240037
- Device name
- Revi System
- Applicant
- Bluewind Medical , Ltd. IL
- Product code
- QXM — Implanted Tibial Electrical Urinary Continence Devic
- Decision date
- 2024-05-02
- Date received
- 2024-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240037.pdf
Official FDA record: K240037
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.