K232525 is an FDA 510(k) clearance for the Yoni.Fit Bladder Support, 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 review panel. Regulated under 21 CFR 884.3575.
| 510(k) Number | K232525 FDA.gov |
| FDA Decision | Cleared 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 |