# FZT: Cutter, Surgical

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 52
- Recalls: 6 (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)
- 1977: 12
- 1978: 3
- 1979: 6
- 1980: 2
- 1982: 24
- 1984: 2
- 1987: 1
- 1989: 1
- 2011: 1

## Most-cited predicates
- K821116: Lister Bandage Scissors 5 & 1/2 (1982), cited by 1

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