# HFB: Forceps, Biopsy, Gynecological

- Device class: 1; regulation: 21 CFR 884.4530; FDA's rule: 510(k) exempt
- FDA decisions: 22
- 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)
- 1981: 2
- 1982: 1
- 1984: 2
- 1985: 2
- 1989: 4
- 1990: 2
- 1994: 7
- 1995: 1
- 2002: 1

## Most-cited predicates
- K842112: Tischler Cervical Biopsy Punch Forceps (1984), cited by 1

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