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 KARL STORZ Endoscopy-America, Inc., Aesculap, Inc. and Penumbra, Inc..
93
Total
93
Cleared
157d
Avg days
1992
Since
93 devices
Cleared
May 16, 2017
KARL STORZ ShuntScope
KARL STORZ Endoscopy-America, Inc.
Neurology
90d
Cleared
Mar 16, 2017
TIPCAM 1S 3D System
KARL STORZ Endoscopy-America, Inc.
Neurology
153d
Cleared
Sep 17, 2016
KARL STORZ Flexible Video-Neuro-Endoscope System
KARL STORZ Endoscopy-America, Inc.
Neurology
150d
Cleared
Mar 17, 2016
Apollo System
Penumbra, Inc.
Neurology
178d
Cleared
Nov 14, 2014
MINOP Disposable Introducer 26F
Aesculap, Inc.
Neurology
87d
Cleared
Jan 17, 2014
APOLLO SYSTEM
Penumbra, Inc.
Neurology
121d
Cleared
May 09, 2008
KSEA CLEARVISION II, MODEL 40334120
KARL STORZ Endoscopy-America, Inc.
Neurology
256d
Cleared
Jul 29, 2004
NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES
Richard Wolf Medical Instruments Corp.
Neurology
409d
Cleared
Mar 21, 2003
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
Richard Wolf Medical Instruments Corp.
Neurology
259d
Cleared
Oct 08, 2002
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
Olympus Winter & Ibe GmbH
Neurology
235d
Cleared
Jun 26, 2002
KSEA NEUROENDOSCOPES AND ACCESSORIES
KARL STORZ Endoscopy-America, Inc.
Neurology
86d
Cleared
Mar 18, 2002
PAEDISCOPE, MODEL # P010A AND PF011A
Aesculap, Inc.
Neurology
90d
Cleared
Nov 03, 2000
KSEA MINIATURE NEUROENDOSCOPE
KARL STORZ Endoscopy-America, Inc.
Neurology
65d
Cleared
Oct 23, 2000
KSEA NEURO-FIBERSCOPE
KARL STORZ Endoscopy-America, Inc.
Neurology
46d
Cleared
Jul 19, 2000
KSEA BIPOLAR COAGULATING ELECTRODES
Karl Storz Endoscopy
Neurology
54d
Cleared
Dec 15, 1999
DCI ENDOSCOPE
KARL STORZ Endoscopy-America, Inc.
Neurology
57d
Cleared
Jun 03, 1999
KSEA NEURO-FIBERSCOPE
KARL STORZ Endoscopy-America, Inc.
Neurology
64d
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
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 07, 1996
AESCULAP VENTRICULOSCOPE SYSTEM
Aesculap, Inc.
Neurology
171d
Cleared
Oct 03, 1995
NONPOWERED NEUROSURGICAL INSTRUMENT
United States Surgical, A Division of Tyco Healthc
Neurology
88d