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 Neuwave Medical, Inc., AngioDynamics, Inc. and Covidien, LLC.