FDA Product Code GWM: Device, Monitoring, Intracranial Pressure
Leading manufacturers include Integra Lifesciences Production Corporation, Braincare Desenvolvimento E Inova??o Tecnol?gica S.A. and Raumedic AG.
FDA 510(k) Cleared Device, Monitoring, Intracranial Pressure Devices (Product Code GWM)
About Product Code GWM - Regulatory Context
510(k) Submission Activity
105 total 510(k) submissions under product code GWM since 1978, with 105 receiving FDA clearance (average review time: 149 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under GWM have taken an average of 197 days to reach a decision - up from 147 days historically. Manufacturers should account for longer review timelines in current project planning.
GWM devices are reviewed by the Neurology panel. Browse all Neurology devices →