FDA Product Code MYE: System, Electrogastrography (egg)
Leading manufacturers include Alimetry , Ltd. and G-Tech Medical.
FDA 510(k) Cleared System, Electrogastrography (egg) Devices (Product Code MYE)
About Product Code MYE - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code MYE since 1999, with 7 receiving FDA clearance (average review time: 136 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under MYE have taken an average of 104 days to reach a decision - down from 147 days historically, suggesting improved FDA processing for this classification.
MYE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →