# K132561: Nuro Neuromodulation System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Uro-Solutions, Inc.
- Decided: Nov 5, 2013 after 82 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: 4 generations back to K052025 (2005). 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)
- K101847: Urgent PC Stimulator; Urgent PC Lead Set, Uroplasty, Inc. (2010) Summary page 1.

## Indications for use
The NURO Neuromadulation System (Stimulator model NURO 100) 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/K132561
Methodology: https://510kreport.com/methodology