Revive Reusable Bladder Support— 510(k) K183468

Clearance details

Applicant

Rinovum Subsidiary 2, LLC

Product code

Code HHW

Device class

Class 2

Regulation

21 CFR 884.3575

Advisory panel

Obstetrics/Gynecology

Date received

2018-12-14

Decision date

2019-01-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Monroeville, PA, US

• K253698 — Milex Incontinence Dish Pessaries +3 more2026-01-20
• K250438 — CooperSurgical Milex® Pessaries2025-04-11
• K240798 — Cntrl+ Bladder Support Pessary2024-12-17
• K232677 — Reia pessary2024-05-21
• K232525 — Yoni.Fit Bladder Support2024-05-17

Malfunction

485

Total

485

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1952-2019 — 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, 18 years and older. The device comes in a sealed box, and contains a reusable bladder support and applicator, and disposable strings and travel case. The device is nonperishable and does not have an expiration date.Class II·Terminated·Rinovum Women's Health·20190502

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183468.