# GCY: Apparatus, Suction, Single Patient Use, Portable, Nonpowered

- Device class: 1; regulation: 21 CFR 878.4680; FDA's rule: 510(k) exempt
- FDA decisions: 96
- Recalls: 62 (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)
- 1988: 5
- 1989: 2
- 1990: 3
- 1991: 2
- 1992: 3
- 1993: 11
- 1994: 2
- 1995: 1
- 1996: 2
- 1997: 2

## Most-cited predicates
- K801766: Jackson-Pratt Large Vol. Closed Wound (1980), cited by 1
- K936223: Pressure Irrigating System (1994), cited by 1
- K972703: Redyrob-Closed Wound Drainage System (1997), cited by 1
- K971036: Odontit Autogenous Bone Collection Device (1997), cited by 1

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