K253698

Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes

510(k) number: K253698
Device name: Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes
Applicant: Cooper Surgical CT · US
Product code: HHW — Pessary, Vaginal
Decision date: 2026-01-20
Date received: 2025-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Obstetrics/Gynecology

Also available from FDA: K253698.pdf

Official FDA record: K253698

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.