# LNK: Laser For Gastro-Urology Use

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 60
- 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)
- 1983: 1
- 1984: 8
- 1985: 7
- 1986: 17
- 1987: 16
- 1988: 9
- 1990: 1
- 1993: 1

## Most-cited predicates
- K901723: MDL-2000 Lasertripter (1990), cited by 1

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