# K233548: Uresta®

- Pathway: 510(k) (Traditional)
- Applicant: Resilia, Inc.
- Decided: Apr 3, 2024 after 152 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 5.

## Indications for use
The Uresta bladder support is indicated for use in adult women over 18 years of age who experience stress urinary incontinence (involuntary urine loss, such as a pee leak that occurs when you cough, laugh, sneeze or with some physical tasks).

Source page: https://510kreport.com/device/K233548
Methodology: https://510kreport.com/methodology