GWF · Class II · 21 CFR 882.1870

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..

3
Total
3
Cleared
110d
Avg days
2022
Since

List of Stimulator, Electrical, Evoked Response devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Jan 11, 2026
SafeOp 3: Neural Informatix System
K252842
Alphatec Spine, Inc.
Neurology · 125d
Cleared Apr 19, 2024
SafeOp 3: Neural Informatix Systeem
K234092
Alphatec Spine, Inc.
Neurology · 115d
Cleared Mar 09, 2022
SafeOp 2: Neural Informatix System
K213849
Alphatec Spine, Inc.
Neurology · 89d

How to use this database

This page lists all FDA 510(k) submissions for Stimulator, Electrical, Evoked Response devices (product code GWF). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Neurology FDA review panel. Browse all Neurology devices →