# GEJ: Carrier, Ligature

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 5
- 510(k) review time 2021–2025: median 101 days (middle half 101–101)
- Recalls: 1 (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)
- 1987: 1
- 1988: 1
- 1990: 2
- 2024: 1

## Most-cited predicates
- K900958: GS-1300 Atraumatic Grasping Forcep, Curved, 10MM (1990), cited by 1

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