FDA Product Code GYB: Media, Electroconductive
Leading manufacturers include Shenzhen Ulike Smart Electronics Co., Ltd..
FDA 510(k) Cleared Media, Electroconductive Devices (Product Code GYB)
About Product Code GYB - Regulatory Context
510(k) Submission Activity
69 total 510(k) submissions under product code GYB since 1977, with 69 receiving FDA clearance (average review time: 151 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under GYB have taken an average of 124 days to reach a decision - down from 151 days historically, suggesting improved FDA processing for this classification.
GYB devices are reviewed by the Neurology panel. Browse all Neurology devices →