FDA Product Code GYC: Electrode, Cortical
Leading manufacturers include Precision Neuroscience, Corp. and Neuralynx, Inc..
FDA 510(k) Cleared Electrode, Cortical Devices (Product Code GYC)
About Product Code GYC - Regulatory Context
510(k) Submission Activity
32 total 510(k) submissions under product code GYC since 1985, with 32 receiving FDA clearance (average review time: 214 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under GYC have taken an average of 149 days to reach a decision - down from 218 days historically, suggesting improved FDA processing for this classification.
GYC devices are reviewed by the Neurology panel. Browse all Neurology devices →