# GYK: Instrument, Shunt System Implantation

- Device class: 1; regulation: 21 CFR 882.4545; FDA's rule: 510(k) exempt
- FDA decisions: 13
- Recalls: 1 (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)
- 1977: 1
- 1979: 1
- 1984: 1
- 1985: 2
- 1987: 2
- 1988: 1
- 1989: 1
- 1993: 3
- 1996: 1

## Most-cited predicates
- K883607: Peel-Away Introducer for Ventricular Catheter (1988), cited by 1

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