FDA Product Code GZL: Electrode, Depth
Leading manufacturers include Ice Neurosystems, Inc., Neuroone Medical Technologies Corp. and Sensomedical Labs, Ltd..
FDA 510(k) Cleared Electrode, Depth Devices (Product Code GZL)
About Product Code GZL - Regulatory Context
510(k) Submission Activity
58 total 510(k) submissions under product code GZL since 1980, with 58 receiving FDA clearance (average review time: 175 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 6 in the prior period.
FDA Review Time
Recent submissions under GZL have taken an average of 142 days to reach a decision - down from 177 days historically, suggesting improved FDA processing for this classification.
GZL devices are reviewed by the Neurology panel. Browse all Neurology devices →