# GAX: Tourniquet, Nonpneumatic

- Device class: 1; regulation: 21 CFR 878.5900; FDA's rule: 510(k) exempt
- FDA decisions: 20
- 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)
- 1978: 2
- 1979: 1
- 1981: 1
- 1982: 2
- 1983: 1
- 1984: 2
- 1985: 4
- 1987: 3
- 1988: 3
- 1993: 1

## Most-cited predicates
- K875092: Degania Silicone Tourniquet (1988), cited by 1

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