# K250438: CooperSurgical Milex® Pessaries

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Apr 11, 2025 after 56 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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® Shaatz Folding Pessaries: Shaatz pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage I and Stage II prolapse, complicated by a mild cystocele. Milex® Gellhorn Pessaries: Gellhorn pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage III prolapse or procidentia. Milex® Ring Folding Pessaries: Milex Ring 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.

Source page: https://510kreport.com/device/K250438
Methodology: https://510kreport.com/methodology