# EZO: Urethrotome

- Device class: 2; regulation: 21 CFR 876.4770; FDA's rule: 510(k) exempt
- FDA decisions: 5
- 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)
- 1992: 1
- 1994: 1
- 1995: 1
- 1996: 1
- 2000: 1

## Most-cited predicates
- K904939: Flexible and Rigid Ureterotome System (1992), cited by 2

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