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 KARL STORZ Endoscopy-America, Inc., Aesculap, Inc. and Penumbra, Inc..

93
Total
93
Cleared
157d
Avg days
1992
Since
93 devices
25–48 of 93
Cleared May 16, 2017
KARL STORZ ShuntScope
K170462
KARL STORZ Endoscopy-America, Inc.
Neurology · 90d
Cleared Mar 16, 2017
TIPCAM 1S 3D System
K162880
KARL STORZ Endoscopy-America, Inc.
Neurology · 153d
Cleared Sep 17, 2016
KARL STORZ Flexible Video-Neuro-Endoscope System
K161112
KARL STORZ Endoscopy-America, Inc.
Neurology · 150d
Cleared Mar 17, 2016
Apollo System
K152699
Penumbra, Inc.
Neurology · 178d
Cleared Nov 14, 2014
MINOP Disposable Introducer 26F
K142315
Aesculap, Inc.
Neurology · 87d
Cleared Jan 17, 2014
APOLLO SYSTEM
K132931
Penumbra, Inc.
Neurology · 121d
Cleared May 09, 2008
KSEA CLEARVISION II, MODEL 40334120
K072410
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
K031858
Richard Wolf Medical Instruments Corp.
Neurology · 409d
Cleared Mar 21, 2003
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
K022198
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
K020507
Olympus Winter & Ibe GmbH
Neurology · 235d
Cleared Jun 26, 2002
KSEA NEUROENDOSCOPES AND ACCESSORIES
K021050
KARL STORZ Endoscopy-America, Inc.
Neurology · 86d
Cleared Mar 18, 2002
PAEDISCOPE, MODEL # P010A AND PF011A
K014149
Aesculap, Inc.
Neurology · 90d
Cleared Nov 03, 2000
KSEA MINIATURE NEUROENDOSCOPE
K002704
KARL STORZ Endoscopy-America, Inc.
Neurology · 65d
Cleared Oct 23, 2000
KSEA NEURO-FIBERSCOPE
K002788
KARL STORZ Endoscopy-America, Inc.
Neurology · 46d
Cleared Jul 19, 2000
KSEA BIPOLAR COAGULATING ELECTRODES
K001630
Karl Storz Endoscopy
Neurology · 54d
Cleared Dec 15, 1999
DCI ENDOSCOPE
K993539
KARL STORZ Endoscopy-America, Inc.
Neurology · 57d
Cleared Jun 03, 1999
KSEA NEURO-FIBERSCOPE
K991069
KARL STORZ Endoscopy-America, Inc.
Neurology · 64d
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 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 07, 1996
AESCULAP VENTRICULOSCOPE SYSTEM
K954394
Aesculap, Inc.
Neurology · 171d
Cleared Oct 03, 1995
NONPOWERED NEUROSURGICAL INSTRUMENT
K953173
United States Surgical, A Division of Tyco Healthc
Neurology · 88d