# FCF: Instrument, Biopsy, Mechanical, Gastrointestinal

- Device class: 2; regulation: 21 CFR 876.1075; FDA's rule: 510(k) required
- FDA decisions: 6
- Recalls: 0 (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)
- 1984: 1
- 1991: 1
- 1992: 1
- 1999: 1
- 2006: 1
- 2007: 1

## Most-cited predicates
- K062833: Powered EZ-IO Bone Marrow Aspiration System (2006), cited by 3
- K070759: Powered EZ-IO Pediatric Bone Marrow Aspiration System (2007), cited by 1

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