# K962009: Urostym

- Pathway: 510(k) (Traditional)
- Applicant: Laborie Medical Technologies, Ltd.
- Decided: May 20, 1997 after 363 days
- Product code: KPI (Stimulator, Electrical, Non-Implantable, For Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Laborie UROSTYM™ is intended to be used in treating urinary incontinence (stress incontinence (hypermobility) and bladder instability} by way of perineal reeducation. Using the available accessories, the system can be used for performing biofeedback and electro-stimulation therapy as treatment modalities for urinary incontinence.

Source page: https://510kreport.com/device/K962009
Methodology: https://510kreport.com/methodology