CooperSurgical Milex® Pessaries— 510(k) K250438

Substantially Equivalent

CooperSurgical, Inc.

FDA 510(k) clearance K250438 for CooperSurgical Milex® Pessaries, Substantially Equivalent on 2025-04-11. Applicant: CooperSurgical, Inc..

Clearance details

Applicant: CooperSurgical, Inc.
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 2025-02-14
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trumbull, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HHW

product code HHW

Malfunction: 485
Total: 485

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.