# QON: Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

- Device class: 3; regulation: 21 CFR 876.5270; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 1 (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: 25
- 2020: 42
- 2021: 34
- 2022: 46
- 2023: 31
- 2024: 35
- 2025: 34
- 2026: 33

## Most-cited predicates

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