K232525 is an FDA 510(k) clearance for the Yoni.Fit Bladder Support. This device is classified as a Pessary, Vaginal (Class II - Special Controls, product code HHW).
Submitted by Watkins-Conti Products, Inc. (Edmond, US). The FDA issued a Cleared decision on May 17, 2024, 270 days after receiving the submission on August 21, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.3575.
| 510(k) Number | K232525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2023 |
| Decision Date | May 17, 2024 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | HHW - Pessary, Vaginal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.3575 |