# EXF: Bag, Bile Collecting

- Device class: 2; regulation: 21 CFR 876.5010; FDA's rule: 510(k) exempt
- FDA decisions: 9
- Recalls: 3 (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)
- 1990: 2
- 1991: 1
- 1994: 1
- 1996: 1
- 1997: 1
- 1998: 1
- 1999: 1
- 2000: 1

## Most-cited predicates
- K963849: Manan D Bag (1996), cited by 1
- K961986: Manan D Bag (1997), cited by 1

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