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., Canyon Medical, Inc. and Varian Medical Systems, Inc..
FDA 510(k) Cleared System, Ablation, Microwave And Accessories Devices (Product Code NEY)
About Product Code NEY - Regulatory Context
510(k) Submission Activity
68 total 510(k) submissions under product code NEY since 2001, with 68 receiving FDA clearance (average review time: 177 days).
Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 13 in the prior period.
FDA Review Time
Recent submissions under NEY have taken an average of 120 days to reach a decision - down from 183 days historically, suggesting improved FDA processing for this classification.
NEY devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →