# FCL: Forceps, Biopsy, Non-Electric

- Device class: 1; regulation: 21 CFR 876.1075; FDA's rule: 510(k) exempt
- FDA decisions: 39
- Recalls: 6 (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)
- 1989: 1
- 1990: 4
- 1991: 4
- 1992: 2
- 1993: 3
- 1994: 7
- 1995: 6
- 1996: 3
- 1997: 2
- 2003: 1

## Most-cited predicates
- K955065: Olympus FB Series Biopsy Forceps (1996), cited by 3
- K900015: Non-Electric Biopsy Forceps (1990), cited by 1
- K912549: Bard (R) Disposable Biopsy Forceps (1991), cited by 1
- K935070: Grasping Forceps, Biopsy Forceps, Spoon Forceps (1994), cited by 1

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