FDA Product Code GWF: Stimulator, Electrical, Evoked Response
Under FDA product code GWF, evoked response electrical stimulators are cleared for intraoperative neurophysiological monitoring.
These devices deliver controlled electrical stimuli to sensory or motor pathways to evoke measurable neural responses that indicate the integrity of specific neural structures. They are used in spinal, cerebrovascular, and skull base surgery to detect neural compromise before permanent injury occurs.
GWF devices are Class II medical devices, regulated under 21 CFR 882.1870 and reviewed by the FDA Neurology panel.
Leading manufacturers include Alphatec Spine, Inc., Natus Neurology Incorporated and Cadwell Industries, Inc..
FDA 510(k) Cleared Stimulator, Electrical, Evoked Response Devices (Product Code GWF)
About Product Code GWF - Regulatory Context
510(k) Submission Activity
139 total 510(k) submissions under product code GWF since 1978, with 139 receiving FDA clearance (average review time: 162 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
Recent submissions under GWF have taken an average of 69 days to reach a decision - down from 165 days historically, suggesting improved FDA processing for this classification.
GWF devices are reviewed by the Neurology panel. Browse all Neurology devices →