# GFG: Bit, Surgical

- Device class: 1; regulation: 21 CFR 878.4820; FDA's rule: 510(k) exempt
- FDA decisions: 3
- Recalls: 2 (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
- 1994: 1

## Most-cited predicates

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