K250438 is an FDA 510(k) clearance for the CooperSurgical Milex? Pessaries, a Pessary, Vaginal (Class II — Special Controls, product code HHW), submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on April 11, 2025, 56 days after receiving the submission on February 14, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.3575.
| 510(k) Number | K250438 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 14, 2025 |
| Decision Date | April 11, 2025 |
| Days to Decision | 56 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 |