About This 510(k) Submission
K253698 is an FDA 510(k) clearance for the Milex? Incontinence Dish Pessaries; Milex? Incontinence Dish Pessaries with Support; Milex? Cube Pessaries; Milex? Cube Pessaries with Drainage Holes, a Pessary, Vaginal (Class II — Special Controls, product code HHW), submitted by Cooper Surgical (Trumbull, US). The FDA issued a Cleared decision on January 20, 2026, 57 days after receiving the submission on November 24, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.3575.