# GFF: Bur, Surgical, General & Plastic Surgery

- Device class: 1; regulation: 21 CFR 878.4820; FDA's rule: 510(k) exempt
- FDA decisions: 16
- Recalls: 7 (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)
- 1982: 2
- 1984: 1
- 1985: 2
- 1986: 1
- 1987: 1
- 1988: 3
- 1989: 2
- 1994: 2
- 1995: 1
- 1998: 1

## Most-cited predicates

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