# GXE: Leukotome

- Device class: 1; regulation: 21 CFR 882.4600; FDA's rule: 510(k) exempt
- FDA decisions: 1
- 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)
- 1992: 1

## Most-cited predicates
- K915741: Disposable Monoplar Meddle Electrodes (1992), cited by 1

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