# FEH: Electrode, Flexible Suction Coagulator

- Device class: 2; regulation: 21 CFR 876.4300; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 1981: 1
- 2012: 1
- 2013: 1

## Most-cited predicates
- K122593: Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2 (2012), cited by 1
- K803214: Acmi Bipolar Hemostatic Electrode (1981), cited by 1

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