FDA Product Code NEY: System, Ablation, Microwave And Accessories
FDA product code NEY covers microwave ablation systems and their accessories used for soft tissue ablation.
These systems use microwave energy delivered through a needle-like antenna to generate heat and destroy targeted tissue. Microwave ablation achieves larger ablation zones and faster treatment times than radiofrequency ablation and is used in the treatment of liver, lung, kidney, and bone tumors.
NEY devices are Class II medical devices, regulated under 21 CFR 878.4400 and reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include AngioDynamics, Inc., Varian Medical Systems, Inc. and Medtronic, Inc..
List of System, Ablation, Microwave And Accessories devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Ablation, Microwave And Accessories devices (product code NEY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →