# GEN: Forceps, General & Plastic Surgery

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 104
- Recalls: 8 (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)
- 1985: 20
- 1986: 3
- 1987: 6
- 1988: 4
- 1989: 3
- 1990: 4
- 1991: 2
- 1993: 1
- 1995: 1
- 2003: 1

## Most-cited predicates
- K900948: GS-1002 Grasping Forcep, 5MM with Ratchet (1990), cited by 1
- K781448: Harrington Hook Clamp (1978), cited by 1
- K031828: Naturalase LP ND:Yag Laser (2003), cited by 1

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