FDA Product Code GXY: Electrode, Cutaneous
Leading manufacturers include Ceribell, Inc., Guangzhou Xinbo Electronic Co., Ltd. and Bionit Labs Srl.
FDA 510(k) Cleared Electrode, Cutaneous Devices (Product Code GXY)
About Product Code GXY - Regulatory Context
510(k) Submission Activity
434 total 510(k) submissions under product code GXY since 1976, with 434 receiving FDA clearance (average review time: 127 days).
Submission volume has declined in recent years - 15 submissions in the last 24 months compared to 19 in the prior period.
FDA Review Time
Recent submissions under GXY have taken an average of 147 days to reach a decision - up from 127 days historically. Manufacturers should account for longer review timelines in current project planning.
GXY devices are reviewed by the Neurology panel. Browse all Neurology devices →