# GAB: Needle, Suturing, Disposable

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 8
- Recalls: 2 (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)
- 1980: 1
- 1981: 1
- 1983: 1
- 1986: 1
- 1989: 1
- 1993: 1
- 1998: 1
- 2001: 1

## Most-cited predicates
- K932591: Endo-Judge (1993), cited by 3
- K980988: Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls) (1998), cited by 3
- K012199: Digicap (2001), cited by 1

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