# K031463: Marina Medical Silicone Pessary

- Pathway: 510(k) (Traditional)
- Applicant: Marina Medical Instruments, Inc.
- Decided: Nov 18, 2003 after 194 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 K013289 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013289: Bioteque Vaginal Pessaries, Bioteque America, Inc. (2001)

## Indications for use
This device is made out of silicone, and it is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. It is available with different sizes of the following models: CUBE (with and without drain), OVAL (with and without support), HODGE (with and without support), SHAATZ, GELLHORN (with and without drains), RING (with and without support), DONUT, GEHRUNG, DISH (with and without support), & MAR-LAND (with and without support). CUBE: indicated for use for the support of a third-degree prolapse. OVAL: indicated for use for the support of a first or mild second-degree prolapse. HODGE: indicated for use for the support of a uterine retroversion. SHAATZ: indicated for use for the support of a first or mild second-degree prolapse. GELLHORN: indicated for use for the support of a third-degree prolapse or procidentia. RING: indicated for use for the support of a first or mild second-degree prolapse. DONUT: indicated for use for the support of a third-degree prolapse. GEHRUNG: indicated for use for the support of cystocele or rectocele. DISH: indicated for use for the control of stress urinary incontinence or a first or mild second-degree prolapse. It restores continence by applying gentle pressure to the urethra. MAR-LAND: indicated for use for the control of stress urinary incontinence or a first or mild second-degree prolapse. It restores continence by applying gentle pressure tQ the uretftrr

Source page: https://510kreport.com/device/K031463
Methodology: https://510kreport.com/methodology