# KYG: Device, Irrigation, Ocular Surgery

- Device class: 1; regulation: 21 CFR 886.4360; FDA's rule: 510(k) exempt
- FDA decisions: 40
- Recalls: 11 (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: 1
- 1994: 3
- 1995: 1
- 1996: 1
- 1997: 2
- 1998: 3
- 1999: 1
- 2000: 1
- 2001: 1

## Most-cited predicates
- K981116: Sovereign Cataract Extraction System (1998), cited by 9
- K940392: Peregrine Pic Minipulator (1994), cited by 1
- K821897: LENS (1983), cited by 1
- K954842: D.O.R.C. Vfi/Vfe System (1996), cited by 1

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