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
Cleared
Oct 23, 2000
KSEA NEURO-FIBERSCOPE
KARL STORZ Endoscopy-America, Inc.
Neurology
46d
Cleared
Oct 18, 2000
NAVIGUS PEEL AWAY INTRODUCER
Image-Guided Neurologics, Inc.
Neurology
78d
Cleared
Jul 19, 2000
KSEA BIPOLAR COAGULATING ELECTRODES
Karl Storz Endoscopy
Neurology
54d
Cleared
Mar 13, 2000
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
Machida Endoscope Co., Ltd.
Neurology
144d
Cleared
Dec 15, 1999
DCI ENDOSCOPE
KARL STORZ Endoscopy-America, Inc.
Neurology
57d
Cleared
Aug 27, 1999
MITAKA POINT SETTER
Mitaka USA, Inc.
Neurology
74d
Cleared
Jun 03, 1999
KSEA NEURO-FIBERSCOPE
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
Medtronic PS Medical
Neurology
84d
Cleared
Jan 27, 1999
ENDIUS SPINE ENDOSCOPE
Endius, Inc.
Neurology
169d
Cleared
Dec 18, 1998
AESCULAP MINOP SYSTEM
Aesculap, Inc.
Neurology
85d
Cleared
Nov 06, 1998
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
Karl Storz Endoscopy
Neurology
86d
Cleared
Jul 29, 1998
OLYMPUS NEURO ENDOSCOPE
Olympus Optical, Co.
Neurology
475d
Cleared
Mar 18, 1998
INCL II ENDOSCOPE
Sofamor Danek USA,Inc.
Neurology
552d
Cleared
Oct 29, 1997
NEUROLOGICAL ENDOSCOPE
Richard Wolf Medical Instruments Corp.
Neurology
286d
Cleared
Apr 21, 1997
AESCULAP ANGLED NEUROENDOSCOPES
Aesculap, Inc.
Neurology
175d
Cleared
Mar 06, 1997
2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS
Neuro Navigational Corp.
Neurology
77d
Cleared
Dec 24, 1996
CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX
Clarus Medical Systems, Inc.
Neurology
293d
Cleared
Jun 13, 1996
NEUROVIEW SCISSORS
Neuro Navigational Corp.
Neurology
63d
Cleared
Jun 07, 1996
1.2MM REUSABLE NEUROVIEW ENDOSCOPE
Neuro Navigational Corp.
Neurology
74d
Cleared
Jun 07, 1996
ASPIRATION/IRRIGATION CATHETER
Neuro Navigational Corp.
Neurology
64d
Cleared
Apr 11, 1996
DISPOSABLE NEUROVIEW INTRODUCER SHEATH
Neuro Navigational Corp.
Neurology
44d
Cleared
Mar 07, 1996
AESCULAP VENTRICULOSCOPE SYSTEM
Aesculap, Inc.
Neurology
171d
Cleared
Mar 07, 1996
DISPOSABLE NEUROVIEW OPERATING SHEATH
Neuro Navigational Corp.
Neurology
129d
Cleared
Feb 29, 1996
NEUROVIEW COAXIAL BIPOLAR ELECTRODE
Neuro Navigational Corp.
Neurology
100d