K253698 is an FDA 510(k) clearance for the Milex™ Incontinence Dish Pessaries. This device is classified as a Pessary, Vaginal (Class II - Special Controls, product code HHW).
Submitted by Cooper Surgical (Trumbull, US). The FDA issued a Cleared decision on January 20, 2026, 57 days after receiving the submission on November 24, 2025.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.3575.
| 510(k) Number | K253698 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2025 |
| Decision Date | January 20, 2026 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHW - Pessary, Vaginal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.3575 |