510(k) K252391 ยท QXM Implanted Tibial Electrical Urinary Continence Device
Revi System
| Applicant | Bluewind Medical , Ltd., Herzliya, IL |
| Decision | Substantially Equivalent, Dec 12, 2025 |
| Received | Jul 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252391
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.