# NAM: Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

- Device class: 2; regulation: 21 CFR 876.5310; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 475 days (middle half 442–507)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2000: 1
- 2005: 1
- 2006: 1
- 2007: 1
- 2010: 1
- 2013: 1
- 2021: 1
- 2023: 1

## Most-cited predicates
- K071822: Urgent PC Neuromodulation System, Models UPC200 and UPC250-12 (2007), cited by 2
- K061333: Urgent PC Neuromodulation System, Models UPC200-a and UPC250-12 (2006), cited by 1
- K101847: Urgent PC Stimulator; Urgent PC Lead Set (2010), cited by 1
- K052025: Urgent PC Neuromodulation System (2005), cited by 1
- K192731: ZIDA Wearable Neuromodulation System (2021), cited by 1

Source page: https://510kreport.com/product-code/NAM
Data by year (CSV): https://510kreport.com/product-code/NAM.csv