Yoni.Fit Bladder Support
FDA 510(k) clearance K232525 · decided 2024-05-17
Clearance details
- K-number
- K232525
- Device name
- Yoni.Fit Bladder Support
- Applicant
- Watkins-Conti Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-21
- Decision date
- 2024-05-17
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- HHW
- Device class
- 2
- Regulation number
- 884.3575
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Edmond, OK, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes (K253698) | Cooper Surgical | 2026-01-20 |
| CooperSurgical Milex® Pessaries (K250438) | CooperSurgical, Inc. | 2025-04-11 |
| Cntrl+ Bladder Support Pessary (K240798) | Cntrl+, Inc. | 2024-12-17 |
| Reia pessary (K232677) | Reia, LLC | 2024-05-21 |
| Uresta® (K233548) | Resilia, Inc. | 2024-04-03 |
| Gynethotics™ Pessary (K231786) | Cosm Medical | 2024-03-06 |
| ProVate Vaginal Support (K190277) | Contipi Medical , Ltd. | 2019-07-08 |
| Revive Reusable Bladder Support (K183468) | Rinovum Subsidiary 2, LLC | 2019-01-25 |
| Panpac Flexi Shelf Pessary (K173351) | Panpac Medical Corporation | 2018-10-31 |
| Panpac Disposable Pessary Fitting Set (K153422) | Panpac Medical Corporation | 2016-07-14 |
| Always/Tampax bladder supports (K151413) | Procter & Gamble | 2015-12-18 |
| PESSARY (K132313) | Eis Corporation | 2014-12-05 |
Recalls involving this device
No recalls on record reference this clearance.