# LGF: Component, Cast

- Device class: 1; regulation: 21 CFR 888.5940; FDA's rule: 510(k) exempt
- FDA decisions: 31
- Recalls: 0 (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)
- 1986: 4
- 1987: 5
- 1988: 1
- 1990: 2
- 1991: 1
- 1993: 1
- 1994: 1
- 1996: 1
- 1997: 2
- 2005: 1

## Most-cited predicates
- K043526: Silverseal Tubular Wound Dressing with X-Static (2005), cited by 1

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