FDA Product Code GWJ: Stimulator, Auditory, Evoked Response
Leading manufacturers include Path Medical GmbH, Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) and Vivosonic, Inc..
FDA 510(k) Cleared Stimulator, Auditory, Evoked Response Devices (Product Code GWJ)
About Product Code GWJ - Regulatory Context
510(k) Submission Activity
76 total 510(k) submissions under product code GWJ since 1977, with 76 receiving FDA clearance (average review time: 114 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under GWJ have taken an average of 85 days to reach a decision - down from 114 days historically, suggesting improved FDA processing for this classification.
GWJ devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →