# FZX: Guide, Surgical, Instrument

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 19
- Recalls: 15 (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)
- 1979: 2
- 1980: 1
- 1981: 2
- 1982: 1
- 1983: 1
- 1984: 6
- 1985: 2
- 1986: 1
- 1987: 2
- 1994: 1

## Most-cited predicates
- K871413: Civco Stepper (1987), cited by 5
- K802093: Gabbay-Frater Suture Guide (1980), cited by 1

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