# FDE: Laparoscopy Kit

- Device class: 2; regulation: 21 CFR 876.1500
- FDA decisions: 4
- Recalls: 54 (19 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1991: 1
- 1994: 1
- 1995: 1
- 1996: 1

## Most-cited predicates
- K942677: Geenen/Zebra Guidelines (1994), cited by 2
- K912443: Candela Introducer Sheath System (1991), cited by 1

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