K250438 is an FDA 510(k) clearance for the CooperSurgical Milex® Pessaries. This device is classified as 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 FDA review panel. Regulated under 21 CFR 884.3575.
| 510(k) Number | K250438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |