GWG · Class II · 21 CFR 882.1480

FDA Product Code GWG: Endoscope, Neurological

Direct visualization of the brain and spinal canal enables minimally invasive neurosurgical procedures. FDA product code GWG covers neurological endoscopes and their accessories.

These rigid or flexible endoscopes provide direct optical access to the ventricular system, spinal canal, and intracranial spaces for the treatment of hydrocephalus, intraventricular tumors, and syringomyelia through minimally invasive approaches.

GWG devices are Class II medical devices, regulated under 21 CFR 882.1480 and reviewed by the FDA Neurology panel.

Leading manufacturers include Neuro Navigational Corp., KARL STORZ Endoscopy-America, Inc. and Clarus Medical Systems, Inc..

95
Total
95
Cleared
159d
Avg days
1992
Since
95 devices
49–72 of 95
Cleared Oct 23, 2000
KSEA NEURO-FIBERSCOPE
K002788
KARL STORZ Endoscopy-America, Inc.
Neurology · 46d
Cleared Oct 18, 2000
NAVIGUS PEEL AWAY INTRODUCER
K002330
Image-Guided Neurologics, Inc.
Neurology · 78d
Cleared Jul 19, 2000
KSEA BIPOLAR COAGULATING ELECTRODES
K001630
Karl Storz Endoscopy
Neurology · 54d
Cleared Mar 13, 2000
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
K993568
Machida Endoscope Co., Ltd.
Neurology · 144d
Cleared Dec 15, 1999
DCI ENDOSCOPE
K993539
KARL STORZ Endoscopy-America, Inc.
Neurology · 57d
Cleared Aug 27, 1999
MITAKA POINT SETTER
K991989
Mitaka USA, Inc.
Neurology · 74d
Cleared Jun 03, 1999
KSEA NEURO-FIBERSCOPE
K991069
KARL STORZ Endoscopy-America, Inc.
Neurology · 64d
Cleared Apr 28, 1999
MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015
K990333
Medtronic PS Medical
Neurology · 84d
Cleared Jan 27, 1999
ENDIUS SPINE ENDOSCOPE
K982819
Endius, Inc.
Neurology · 169d
Cleared Dec 18, 1998
AESCULAP MINOP SYSTEM
K983365
Aesculap, Inc.
Neurology · 85d
Cleared Nov 06, 1998
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
K982837
Karl Storz Endoscopy
Neurology · 86d
Cleared Jul 29, 1998
OLYMPUS NEURO ENDOSCOPE
K971340
Olympus Optical, Co.
Neurology · 475d
Cleared Mar 18, 1998
INCL II ENDOSCOPE
K963642
Sofamor Danek USA,Inc.
Neurology · 552d
Cleared Oct 29, 1997
NEUROLOGICAL ENDOSCOPE
K970162
Richard Wolf Medical Instruments Corp.
Neurology · 286d
Cleared Apr 21, 1997
AESCULAP ANGLED NEUROENDOSCOPES
K964281
Aesculap, Inc.
Neurology · 175d
Cleared Mar 06, 1997
2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS
K965078
Neuro Navigational Corp.
Neurology · 77d
Cleared Dec 24, 1996
CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX
K960915
Clarus Medical Systems, Inc.
Neurology · 293d
Cleared Jun 13, 1996
NEUROVIEW SCISSORS
K961406
Neuro Navigational Corp.
Neurology · 63d
Cleared Jun 07, 1996
1.2MM REUSABLE NEUROVIEW ENDOSCOPE
K961173
Neuro Navigational Corp.
Neurology · 74d
Cleared Jun 07, 1996
ASPIRATION/IRRIGATION CATHETER
K961300
Neuro Navigational Corp.
Neurology · 64d
Cleared Apr 11, 1996
DISPOSABLE NEUROVIEW INTRODUCER SHEATH
K960792
Neuro Navigational Corp.
Neurology · 44d
Cleared Mar 07, 1996
AESCULAP VENTRICULOSCOPE SYSTEM
K954394
Aesculap, Inc.
Neurology · 171d
Cleared Mar 07, 1996
DISPOSABLE NEUROVIEW OPERATING SHEATH
K954938
Neuro Navigational Corp.
Neurology · 129d
Cleared Feb 29, 1996
NEUROVIEW COAXIAL BIPOLAR ELECTRODE
K955351
Neuro Navigational Corp.
Neurology · 100d