FDA Product Code GYD: Transducer, Tremor
Leading manufacturers include Gkc Manufacturing Pty, Ltd., Rune Labs, Inc. and H2o Bilisim Yazilim.
FDA 510(k) Cleared Transducer, Tremor Devices (Product Code GYD)
About Product Code GYD - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code GYD since 1979, with 12 receiving FDA clearance (average review time: 158 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under GYD have taken an average of 94 days to reach a decision - down from 164 days historically, suggesting improved FDA processing for this classification.
GYD devices are reviewed by the Neurology panel. Browse all Neurology devices →