Clearance Summary
CooperSurgical Milex® Pessaries received FDA 510(k) clearance under submission number K250438, sponsored by CooperSurgical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-04-11.
- Submission: K250438
- Applicant / Sponsor: CooperSurgical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3575
- Decision date: 2025-04-11
Classification & Regulation
This clearance is catalogued under FDA product code HHW and 21 CFR 884.3575, within the Obstetrics/Gynecology review panel as a Class II device.