# EZW: Stimulator, Electrical, Implantable, For Incontinence

- Device class: 3; regulation: 21 CFR 876.5270; FDA's rule: PMA required
- FDA decisions: 4
- Recalls: 7 (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)
- 2017: 27
- 2018: 19
- 2019: 24
- 2020: 43
- 2021: 34
- 2022: 46
- 2023: 32
- 2024: 35
- 2025: 36
- 2026: 37

## Most-cited predicates
- P970004: Medtronic Interstim Therapy System for Urinary Control (1997), cited by 1

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