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 Cadwell Laboratories, Inc., Nihon Kohden America, Inc. and Excel Tech. , Ltd..
140
Total
140
Cleared
163d
Avg days
1978
Since
Growing category -
5 submissions in the last 2 years
vs 4 in the prior period
Review times improving: avg
109d
recently vs 165d historically
FDA 510(k) Cleared Stimulator, Electrical, Evoked Response Devices (Product Code GWF)
140 devices
Cleared
Jan 11, 2026
SafeOp 3: Neural Informatix System
Alphatec Spine, Inc.
Neurology
125d
Cleared
Jan 22, 2025
Nicolet EDX
Natus Neurology Incorporated
Neurology
30d
Cleared
Dec 12, 2024
Natus Ultrapro S100 (982A0594)
Natus Neurology Incorporated
Neurology
30d
Cleared
Nov 05, 2024
Delphi Stimulator
Quantalx Neuroscience
Neurology
90d
Cleared
Apr 19, 2024
SafeOp 3: Neural Informatix Systeem
Alphatec Spine, Inc.
Neurology
115d
Cleared
Mar 25, 2024
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
Soterix Medical, Inc.
Neurology
94d
Cleared
Oct 27, 2023
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Inomed Medizintechnik GmbH
Neurology
28d
Cleared
Aug 17, 2023
Cadwell Guardian
Cadwell Industries, Inc.
Neurology
182d
Cleared
Mar 09, 2022
SafeOp 2: Neural Informatix System
Alphatec Spine, Inc.
Neurology
89d
Cleared
Jan 07, 2022
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
Inomed Medizintechnik GmbH
Neurology
179d
Cleared
Aug 13, 2021
MEGA-TMS
Soterix Medical, Inc.
Neurology
681d
Cleared
May 22, 2021
Neuro-IOM system with Neuro-IOM.NET software
Neurosoft , Ltd.
Neurology
796d
Cleared
Oct 28, 2020
NIM Vital, Nerve Integrity Monitor
Medtronic Xomed, Inc.
Neurology
218d
Cleared
Feb 22, 2019
The EPAD 2 System
Safeop Surgical, Inc.
Neurology
158d
Cleared
May 14, 2010
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
Nuvasive, Inc.
Neurology
134d
Cleared
Jun 08, 2009
NUVASIVE NEURO VISION SYSTEM
Nuvasive, Inc.
Neurology
122d
Cleared
Feb 27, 2009
NIM 3.0
Medtronic Xomed, Inc.
Neurology
128d
Cleared
Oct 06, 2008
SEN-4100 ELECTRIC STIMULATOR
Nihon Kohden America, Inc.
Neurology
447d
Cleared
Oct 29, 2007
NEUROVISION JJB SYSTEM
Nuvasive, Inc.
Neurology
69d
Cleared
Jan 24, 2007
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
Nuvasive, Inc.
Neurology
117d
Cleared
Aug 17, 2005
MEE-1000A NEUROMASTER
Nihon Kohden America, Inc.
Neurology
100d
Cleared
Jul 11, 2005
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
Nuvasive, Inc.
Neurology
45d
Cleared
Nov 03, 2004
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
Cadwell Laboratories, Inc.
Neurology
65d
Cleared
Aug 06, 2004
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
Excel Tech. , Ltd.
Neurology
175d
About Product Code GWF - Regulatory Context
510(k) Submission Activity
140 total 510(k) submissions under product code GWF since 1978, with 140 receiving FDA clearance (average review time: 163 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - GWF Product Code
Recent submissions under GWF have taken an average of 109 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 →