# GEY: Motor, Surgical Instrument, Ac-Powered

- Device class: 1; regulation: 21 CFR 878.4820; FDA's rule: 510(k) exempt
- FDA decisions: 41
- Recalls: 6 (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)
- 1990: 2
- 1991: 4
- 1993: 3
- 1994: 1
- 1995: 4
- 1996: 3
- 1997: 6
- 2001: 1
- 2002: 1
- 2005: 1

## Most-cited predicates
- K012738: Symphony Graft Delivery System (GDS) (2001), cited by 2
- K020621: Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands (2002), cited by 2
- K050519: Advanced Turbo Drive System (2005), cited by 1
- K964073: Bme Bone Drill Bits (1996), cited by 1
- K951118: 3M Maxi-Driver II Electric System (1995), cited by 1

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