K250438
- 510(k) number
- K250438
- Device name
- CooperSurgical Milex® Pessaries
- Applicant
- CooperSurgical, Inc. CT · US
- Product code
- HHW — Pessary, Vaginal
- Decision date
- 2025-04-11
- Date received
- 2025-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250438.pdf
Official FDA record: K250438
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.