# FAT: Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

- Device class: 2; regulation: 21 CFR 876.5365; 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)
- 1978: 1
- 1984: 1
- 1985: 1
- 1990: 1
- 1996: 1
- 1998: 1
- 1999: 1
- 2014: 1

## Most-cited predicates
- K960173: Infra Vision Bougie Kit, Infra Vision Esophageal Kit (1996), cited by 1
- K983220: Stryker Infravision Esophageal Kit (1999), cited by 1
- K972119: Maloney Bouge (1210-XX)/Hurst Bougie (1212-XX) (1998), cited by 1

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