510(k) K183468 ยท HHW Pessary, Vaginal
Revive Reusable Bladder Support
| Applicant | Rinovum Subsidiary 2, LLC, Monroeville PA, US |
| Decision | Substantially Equivalent, Jan 25, 2019 |
| Received | Dec 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2019 | Rinovum Women's Health Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women Terminated |
HHW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.