# K083769: Modification to Uresta Pessary

- Pathway: 510(k) (Special)
- Applicant: Eastmed, Inc.
- Decided: Jan 14, 2009 after 27 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 K930618 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081385: Uresta Pessary, Eastmed, Inc. (2008) Summary page 1.
- K971303: Instead, Softcup, Ultrafem, Inc. (1997) Summary page 1.

## Most influential descendants
- K232525: Yoni.Fit Bladder Support (2024), 0 descendants of its own

## Indications for use
This device is for use in adult women, over 18 years of age, who experience involuntary urine loss with physical activity (stress urinary incontinence).

Source page: https://510kreport.com/device/K083769
Methodology: https://510kreport.com/methodology