# GDY: Gauze/Sponge, Internal, X-Ray Detectable

- Device class: 1; regulation: 21 CFR 878.4450; FDA's rule: 510(k) exempt
- FDA decisions: 111
- Recalls: 18 (1 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: 4
- 1989: 2
- 1990: 1
- 1991: 4
- 1992: 5
- 1993: 1
- 1994: 27
- 1995: 14
- 1996: 2
- 1997: 1

## Most-cited predicates
- K920355: Specialty Sponges (1992), cited by 1
- K935883: Neurological Sponges (1994), cited by 1
- K953059: Kittner Dissector (1995), cited by 1

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