# EZB: Stylet For Catheter, Gastro-Urology

- Device class: 1; regulation: 21 CFR 876.5130; FDA's rule: 510(k) exempt
- FDA decisions: 3
- 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)
- 1987: 1
- 1997: 2

## Most-cited predicates
- K970994: Core and Coil Assembly Guidewire (1997), cited by 2

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