# K993308: Mentor Evacare Vaginal Pessaries

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Dec 13, 1999 after 70 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: 1 generation back to K904026 (1990). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904026: Inflat-O-Ball, Milex Products, Inc. (1990) Summary page 2.
- K974117: Pelvx Donut, Pelvx Cube, Deschutes Medical Products, Inc. (1998) Summary page 2.
- K974116: Pelvx Incontinence Ring, Deschutes Medical Products, Inc. (1998) Summary page 2.
- K974115: Pelvx Ring, Pelvx Ring with Support, Deschutes Medical Products, Inc. (1998) Summary page 2.
- K920747: Pessary Flexible Silicone Donut Ring, Bioteque America, Inc. (1994) Summary page 2.
- K920187: Flexible Silicone Gelihorn, Bioteque America, Inc. (1992) Summary page 2.

## Most influential descendants
- K253698: Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes (2026), 0 descendants of its own
- K250438: CooperSurgical Milex® Pessaries (2025), 0 descendants of its own

## Indications for use
A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse. Please refer to the attached page for a listing of indications for use for each pessary style. Donut Pessary: Support of third degree prolapse, cystocele and rectocele. Ring Pessary: Support of first or second degree prolapse. Ring with support can also be used on an accompanying cystocele. Dish Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse. Oval Pessary: Support of first or second degree prolapse and accompanying cystocyle. Shaatz Pessary: Support of first or second degree prolapse and accompanying cystocyle. Mar-Land Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse. Hodge Pessary: Support of first to second degree prolapse, a cystocele, stress urinary incontinence and an incompetent cervix or uterine retroversion.. Gehrung Pessary: Support of cystocele and rectocele, as well as support of second to third degree prolapse. Gellhorn Pessary: Support of second to third degree prolapse or procidentia. Cube Pessary: Support of third degree prolapse, procidentia, cystocele, and rectocele. Fitting Set: Used to determine the proper size of pessary for each patient.

Source page: https://510kreport.com/device/K993308
Methodology: https://510kreport.com/methodology