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
Jun 27, 2026
BraiN20® (BraiN20)
Time IS Brain, S.L.
Neurology
271d
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
Apr 05, 2017
Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
Neurovision Medical Product, Inc.
Neurology
30d
Cleared
Mar 31, 2017
MEP Monitor
Tonica Elektronik A/S
Neurology
169d
Cleared
Mar 02, 2017
Cascade IOMAX Intraoperative Monitor
Cadwell Industries, Inc.
Neurology
209d
Cleared
May 16, 2016
MagPro R20
Tonica Elektronik A/S
Neurology
104d
Cleared
Aug 19, 2015
STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
Eb Neuro S.P.A.
Neurology
201d
Cleared
Apr 24, 2015
Neuromaster G1 MEE200
Nihon Kohden Corporation
Neurology
220d
Cleared
Jan 24, 2014
EPAD
Safeop Surgical, Inc.
Neurology
156d
Cleared
Aug 23, 2013
MAGSTIM DOUBLE 70-2 COIL
The Magstim Company , Ltd.
Neurology
185d
Cleared
Jun 05, 2013
NEUROEPG SYSTEM
Strohl Medical Technologies
Neurology
174d
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 →