# K053007: Skylark Uro Probe

- Pathway: 510(k) (Traditional)
- Applicant: Skylark Device & Systems Co., Ltd.
- Decided: Dec 5, 2005 after 40 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. The FDA summary names no predicate by number.

## Indications for use
The Skylark Uro Probe is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and allows assessment of EMG activity of the pelvic floor muscles.

Source page: https://510kreport.com/device/K053007
Methodology: https://510kreport.com/methodology