# K253698: Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes

- Pathway: 510(k) (Traditional)
- Applicant: Cooper Surgical
- Decided: Jan 20, 2026 after 57 days
- Product code: HHW (Pessary, Vaginal)
- Device class: 2
- Regulation: 21 CFR 884.3575
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904026 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132313: Pessary, Eis Corporation (2014) Summary page 5.
- K993308: Mentor Evacare Vaginal Pessaries, Mentor Corp. (1999) Summary page 5.

## Indications for use
The CooperSurgical Milex™ pessaries are intended to provide support to pelvic organs when inserted in the vagina. The following Indications for Use are associated with each of the following pessary styles: Milex™ Incontinence Dish Pessaries and Incontinence Dish Pessaries with Support: Incontinence dish pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women. Milex™ Cube Pessaries and Cube Pessaries with Drainage Holes: Cube pessary is indicated for nonsurgical management of pelvic organ prolapse in Stage III prolapse including rectocele and/or cystocele.

Source page: https://510kreport.com/device/K253698
Methodology: https://510kreport.com/methodology