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., Clearmind Biomedical and Aesculap, Inc..

93
Total
93
Cleared
157d
Avg days
1992
Since
Stable submission activity - 5 submissions in the last 2 years
Review times increasing: avg 183d recently vs 156d historically

FDA 510(k) Cleared Endoscope, Neurological Devices (Product Code GWG)

93 devices
1–24 of 93
Cleared Jun 04, 2026
Precision S 4K Sinuscope
K253602
Stryker Endoscopy
Neurology · 198d
Cleared May 08, 2026
Hydro Irrigation System
K253679
Stryker Instruments
Neurology · 168d
Cleared May 21, 2025
HJY VisualNext 3D Endoscopic Vision System
K243429
Hjy Smart Medical Device Co., Ltd.
Neurology · 197d
Cleared Apr 09, 2025
AURORA® Surgiscope® System (ASX15/60)
K250752
Integra LifeSciences Corporation
Neurology · 28d
Cleared Aug 21, 2024
cCeLL - In vivo
K233391
VPIX Medical, Inc.
Neurology · 324d
Cleared Nov 21, 2023
Digital ClarusScope System, Digital NeuroPEN System
K223615
Clarus Medical, LLC
Neurology · 351d
Cleared Oct 27, 2023
Aurora Surgiscope System
K232618
Rebound Therapeutics Corporation
Neurology · 59d
Cleared Oct 13, 2023
Neuroblade System
K230125
Clearmind Biomedical
Neurology · 269d
Cleared Sep 21, 2023
QEVO System
K232159
Carl Zeiss Meditec, AG
Neurology · 63d
Cleared Jul 28, 2023
HJY VisualNext Endoscopic Vision System
K222735
Hjy Smart Medical Device Co., Ltd.
Neurology · 322d
Cleared Aug 06, 2021
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
K211202
Stryker
Neurology · 106d
Cleared Apr 02, 2021
ClearPath Disposable Introducer
K210251
Clearmind Biomedical
Neurology · 63d
Cleared Mar 18, 2021
Clarus Peel-Away Introducer Sheath
K200925
Clarus Medical, LLC
Neurology · 345d
Cleared Nov 27, 2020
Axonpen, Axonmonitor, Axonbox, Tablet
K201308
Clearmind Biomedical
Neurology · 196d
Cleared Nov 04, 2020
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
K201840
Rebound Therapeutics
Neurology · 125d
Cleared Dec 06, 2019
Aurora Surgiscope System
K191861
Rebound Therapeutics
Neurology · 148d
Cleared Aug 30, 2019
Artemis Eye System
K190719
Penumbra, Inc.
Neurology · 163d
Cleared Jan 18, 2019
Aurora Surgiscope System
K182211
Rebound Therapeutics Corporation
Neurology · 156d
Cleared Nov 20, 2018
MR Compatible Aspiration Kit
K181731
Mri Interventions, Inc.
Neurology · 144d
Cleared Oct 25, 2018
CONVIVO
K181116
Carl Zeiss Meditec, AG
General & Plastic Surgery · 181d
Cleared May 22, 2018
Cellvizio 100 Series Systems with Confocal Miniprobes
K180270
Mauna Kea Technologies
Neurology · 111d
Cleared Apr 17, 2018
KARL STORZ ICG Imaging System
K180146
KARL STORZ Endoscopy-America, Inc.
Neurology · 89d
Cleared Aug 14, 2017
Artemis Neuro Evacuation Device
K171332
Penumbra, Inc.
Neurology · 98d
Cleared May 16, 2017
KARL STORZ ShuntScope
K170462
KARL STORZ Endoscopy-America, Inc.
Neurology · 90d

About Product Code GWG - Regulatory Context

510(k) Submission Activity

93 total 510(k) submissions under product code GWG since 1992, with 93 receiving FDA clearance (average review time: 157 days).

Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.

FDA 510(k) Review Time - GWG Product Code

Recent submissions under GWG have taken an average of 183 days to reach a decision - up from 156 days historically. Manufacturers should account for longer review timelines in current project planning.

GWG devices are reviewed by the Neurology panel. Browse all Neurology devices →