FDA Product Code GXZ: Electrode, Needle
Leading manufacturers include Technomed Europe.
FDA 510(k) Cleared Electrode, Needle Devices (Product Code GXZ)
About Product Code GXZ - Regulatory Context
510(k) Submission Activity
53 total 510(k) submissions under product code GXZ since 1978, with 53 receiving FDA clearance (average review time: 194 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under GXZ have taken an average of 238 days to reach a decision - up from 194 days historically. Manufacturers should account for longer review timelines in current project planning.
GXZ devices are reviewed by the Neurology panel. Browse all Neurology devices →