# K101847: Urgent PC Stimulator; Urgent PC Lead Set

- Pathway: 510(k) (Traditional)
- Applicant: Uroplasty, Inc.
- Decided: Oct 21, 2010 after 112 days
- Product code: NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K052025 (2005). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071822: Urgent PC Neuromodulation System, Models UPC200 and UPC250-12, Uroplasty, Inc. (2007) Summary page 1.

## Most influential descendants
- K132561: Nuro Neuromodulation System (2013), 0 descendants of its own

## Indications for use
The Urgent PC Neuromodulation System is intended to treat patients with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

Source page: https://510kreport.com/device/K101847
Methodology: https://510kreport.com/methodology