# GAD: Retractor

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 100
- Recalls: 23 (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)
- 1992: 6
- 1993: 4
- 1994: 4
- 1996: 1
- 1998: 1
- 2000: 1
- 2005: 2
- 2007: 1
- 2013: 1
- 2016: 2

## Most-cited predicates
- K043602: Quadrant Retractor System (2005), cited by 5
- K914190: Auto Suture (R) Endoscopic Fan Retractor (1992), cited by 5
- K942002: Retractor (1994), cited by 2
- K853947: Omni-Tract Chest Wall & Luna Retractor (1985), cited by 1
- K842762: Omni-Tract Surgical Retractor Sys (1984), cited by 1
- K893121: Robotrac (TM) Retractor Arm (1989), cited by 1
- K922626: Adept Instrument Positioning Accessory (1992), cited by 1
- K872919: Omni-Tract Corral Retractor (1987), cited by 1

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