510(k) K250438
K250438 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "CooperSurgical Milex® Pessaries". The FDA issued a decision of Substantially Equivalent on April 11, 2025. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2025
- Date Received
- February 14, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pessary, Vaginal
- Device Class
- Class II
- Regulation Number
- 884.3575
- Review Panel
- OB
- Submission Type