# HFG: Coagulator, Laparoscopic, Unipolar (And Accessories)

- Device class: 2; regulation: 21 CFR 884.4160; FDA's rule: 510(k) required
- FDA decisions: 11
- 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)
- 1990: 1
- 1991: 1
- 1992: 1
- 1994: 1
- 1996: 1
- 1999: 1
- 2010: 1
- 2012: 1
- 2014: 2
- 2018: 1

## Most-cited predicates
- K121858: The Ablation System (2012), cited by 3
- K132744: Acessa Guidance System (2014), cited by 1
- K991424: Insulscan Insulation Testing System (1999), cited by 1

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