# FFE: System, Water Jet Catheter, Renal

- Device class: 2; regulation: 21 CFR 876.4650; FDA's rule: 510(k) exempt
- FDA decisions: 1
- 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)
- 1997: 1

## Most-cited predicates
- K971328: Olympus CD-6C-1 Coagulation Electrode (1997), cited by 1

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