ClearanceBrief
Panels › Neurology › Product code GWG · Class 2

Endoscope, Neurological

Regulation 882.1480

4510(k)s in 12 months (95 all time)
1recalls in 12 months (22 all time)
18recalls that name a 510(k)
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Top companies in GWG

Company510(k)sRecalls
Neuro Navigational Corp.150
KARL STORZ Endoscopy-America, Inc.100
Aesculap71
Clarus Medical Systems, Inc.70
Karl Storz Endoscopy24
Medtronic Neurosurgery06
Medtronic PS Medical40
Penumbra, Inc.40
Rebound Therapeutics40
Carl Zeiss Meditec, AG30
Decided510(k)Device and applicantCode
Oct 16, 2026K260315cCeLL - In vivo
VPIX Medical, Inc., KR
GWG
Oct 14, 2026K260581KARL STORZ Flexible Video Neuro-Endoscope
Karl Storz SE & CO. KG, DE
GWG
Jun 4, 2026K253602Precision S 4K Sinuscope
Stryker Endoscopy
GWG
May 8, 2026K253679Hydro Irrigation System
Stryker Instruments
GWG
May 21, 2025K243429HJY VisualNext 3D Endoscopic Vision System
Hjy Smart Medical Device Co., Ltd., TW
GWG
Apr 9, 2025K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
Integra LifeSciences Corporation
GWG
Aug 21, 2024K233391cCeLL - In vivo
VPIX Medical, Inc., KR
GWG
Nov 21, 2023K223615Digital ClarusScope System, Digital NeuroPEN System
Clarus Medical, LLC
GWG
Oct 27, 2023K232618Aurora Surgiscope System
Rebound Therapeutics Corporation
GWG
Oct 13, 2023K230125Neuroblade System
Clearmind Biomedical, TW
GWG
Sep 21, 2023K232159QEVO System
Carl Zeiss Meditec, AG, DE
GWG
Jul 28, 2023K222735HJY VisualNext Endoscopic Vision System
Hjy Smart Medical Device Co., Ltd., TW
GWG
Aug 6, 2021K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
Stryker
GWG
Apr 2, 2021K210251ClearPath Disposable Introducer
Clearmind Biomedical, TW
GWG
Mar 18, 2021K200925Clarus Peel-Away Introducer Sheath
Clarus Medical, LLC
GWG
Nov 27, 2020K201308Axonpen, Axonmonitor, Axonbox, Tablet
Clearmind Biomedical, TW
GWG
Nov 4, 2020K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
Rebound Therapeutics
GWG
Dec 6, 2019K191861Aurora Surgiscope System
Rebound Therapeutics
GWG
Aug 30, 2019K190719Artemis Eye System
Penumbra, Inc.
GWG
Jan 18, 2019K182211Aurora Surgiscope System
Rebound Therapeutics Corporation
GWG
Nov 20, 2018K181731MR Compatible Aspiration Kit
Mri Interventions, Inc.
GWG
Oct 25, 2018K181116CONVIVO
Carl Zeiss Meditec, AG, DE
GWG
May 22, 2018K180270Cellvizio 100 Series Systems with Confocal Miniprobes
Mauna Kea Technologies, FR
GWG
Apr 17, 2018K180146KARL STORZ ICG Imaging System
Karl Storz Endoscopy America, Inc.
GWG
Aug 18, 2017K170667QEVO System with KINEVO 900
Carl Zeiss Meditec, AG, DE
GWG
Aug 14, 2017K171332Artemis Neuro Evacuation Device
Penumbra, Inc.
GWG
May 16, 2017K170462KARL STORZ ShuntScope
KARL STORZ Endoscopy-America, Inc.
GWG
Mar 16, 2017K162880TIPCAM 1S 3D System
Karl Storz Endoscopy America, Inc.
GWG
Sep 17, 2016K161112KARL STORZ Flexible Video-Neuro-Endoscope System
KARL STORZ Endoscopy-America, Inc.
GWG
Mar 17, 2016K152699Apollo System
Penumbra, Inc.
GWG
Nov 14, 2014K142315MINOP Disposable Introducer 26F
Aesculap, Inc.
GWG
Jan 17, 2014K132931APOLLO SYSTEM
Penumbra, Inc.
GWG
Jul 16, 2013K131434VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
Visionsense, Ltd.
GWG
May 29, 2008K081102VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
Visionsense, Ltd.
GWG
May 9, 2008K072410KSEA CLEARVISION II, MODEL 40334120
KARL STORZ Endoscopy-America, Inc.
GWG
Jul 11, 2006K061135MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019
Aesculap
GWG
Nov 23, 2005K052745ASSISTO ARM SYSTEMS
Geomed Medizin-Technik GmbH & Co., NL
GWG
Dec 21, 2004K043128OLYMPUS ENDOARM
Olympus Corporation
GWG
Jul 29, 2004K031858NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES
Richard Wolf Medical Instruments Corp.
GWG
Mar 21, 2003K022198ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
Richard Wolf Medical Instruments Corp.
GWG
Oct 8, 2002K020507OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
Olympus Winter & Ibe GmbH
GWG
Aug 20, 2002K013759MSS-28CS-301/701 NEEDLESCOPE
Olympus Optical Co., Ltd.
GWG
Jun 26, 2002K021050KSEA NEUROENDOSCOPES AND ACCESSORIES
KARL STORZ Endoscopy-America, Inc.
GWG
Mar 18, 2002K014149PAEDISCOPE, MODEL # P010A AND PF011A
Aesculap, Inc.
GWG
Apr 20, 2001K010341MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,
Medtronic PS Medical
GWG
Feb 22, 2001K003914MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
Medtronic PS Medical
GWG
Nov 16, 2000K002572MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005
Medtronic PS Medical
GWG
Nov 3, 2000K002704KSEA MINIATURE NEUROENDOSCOPE
KARL STORZ Endoscopy-America, Inc.
GWG
Oct 23, 2000K002788KSEA NEURO-FIBERSCOPE
KARL STORZ Endoscopy-America, Inc.
GWG
Oct 18, 2000K002330NAVIGUS PEEL AWAY INTRODUCER
Image-Guided Neurologics, Inc.
GWG

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