# GES: Blade, Scalpel

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 48
- Recalls: 12 (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)
- 1984: 7
- 1985: 9
- 1986: 5
- 1987: 2
- 1988: 3
- 1990: 1
- 1991: 1
- 1992: 1
- 1993: 2
- 2003: 1

## Most-cited predicates
- K923170: Los Alamos Retractable Knife (1993), cited by 1

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