CooperSurgical Milex® Pessaries

CooperSurgical Milex® Pessaries is an FDA 510(k)-cleared medical device (K250438) manufactured by CooperSurgical, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 10, 2025. Regulation: 8.