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 Cadwell Laboratories, Inc., Nihon Kohden America, Inc. and Excel Tech. , Ltd..

140
Total
140
Cleared
163d
Avg days
1978
Since
140 devices
25–48 of 140
Cleared May 02, 2013
SYNERGY FOCUS DESKTOP VERSION
K130346
Natus Neurology Incorporated
Neurology · 80d
Cleared Sep 19, 2012
MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
K120397
Nihon Kohden Corp.
Neurology · 224d
Cleared May 22, 2012
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
K112881
Nexstim OY
Neurology · 235d
Cleared Apr 25, 2012
CAREFUSION NICOLET EDX
K120979
Carefusion 209, Inc.
Neurology · 23d
Cleared Mar 15, 2012
CAREFUSION NICOLET EDX
K112052
Carefusion 209, Inc.
Neurology · 241d
Cleared Oct 06, 2011
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
K111647
Inomed Medizintechnik GmbH
Neurology · 115d
Cleared Sep 30, 2011
NEUROVISION NERVE LOCATOR MONITOR
K110140
Neurovision Medical Products, Inc.
Neurology · 255d
Cleared May 14, 2010
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
K094054
Nuvasive, Inc.
Neurology · 134d
Cleared Mar 26, 2010
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
K091940
Tonica Elektronik A/S
Neurology · 269d
Cleared Jun 08, 2009
NUVASIVE NEURO VISION SYSTEM
K090298
Nuvasive, Inc.
Neurology · 122d
Cleared Feb 27, 2009
NIM 3.0
K083124
Medtronic Xomed, Inc.
Neurology · 128d
Cleared Oct 06, 2008
SEN-4100 ELECTRIC STIMULATOR
K071969
Nihon Kohden America, Inc.
Neurology · 447d
Cleared Oct 29, 2007
NEUROVISION JJB SYSTEM
K072343
Nuvasive, Inc.
Neurology · 69d
Cleared Jul 27, 2007
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
K071821
Tonica Elektronik A/S
Neurology · 24d
Cleared Jan 24, 2007
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
K062765
Nuvasive, Inc.
Neurology · 117d
Cleared Oct 31, 2006
MAGPRO, MODEL R30
K061645
Tonica Elektronik A/S
Neurology · 141d
Cleared Sep 20, 2005
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A
K051357
Digitimer , Ltd.
Neurology · 119d
Cleared Aug 17, 2005
MEE-1000A NEUROMASTER
K051178
Nihon Kohden America, Inc.
Neurology · 100d
Cleared Aug 15, 2005
ECLIPSE NEUROLOGICAL WORKSTATION
K050798
Axon Systems, Inc.
Neurology · 139d
Cleared Jul 11, 2005
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K051384
Nuvasive, Inc.
Neurology · 45d
Cleared Nov 03, 2004
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
K042350
Cadwell Laboratories, Inc.
Neurology · 65d
Cleared Aug 06, 2004
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
K040358
Excel Tech. , Ltd.
Neurology · 175d
Cleared Apr 02, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
K010092
Excel Tech. , Ltd.
Neurology · 81d
Cleared Mar 26, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
K010090
Excel Tech. , Ltd.
Neurology · 74d