FDA 510(k) Applications for Medical Device Product Code "GWG"
(Endoscope, Neurological)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K061135 | AESCULAP | MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019 | 07/11/2006 |
| K964281 | AESCULAP, INC. | AESCULAP ANGLED NEUROENDOSCOPES | 04/21/1997 |
| K983365 | AESCULAP, INC. | AESCULAP MINOP SYSTEM | 12/18/1998 |
| K954394 | AESCULAP, INC. | AESCULAP VENTRICULOSCOPE SYSTEM | 03/07/1996 |
| K142315 | AESCULAP, INC. | MINOP Disposable Introducer 26F | 11/14/2014 |
| K014149 | AESCULAP, INC. | PAEDISCOPE, MODEL # P010A AND PF011A | 03/18/2002 |
| K181116 | Carl Zeiss Meditec AG | CONVIVO | 10/25/2018 |
| K232159 | Carl Zeiss Meditec AG | QEVO System | 09/21/2023 |
| K170667 | Carl Zeiss Meditec AG | QEVO System with KINEVO 900 | 08/18/2017 |
| K960915 | CLARUS MEDICAL SYSTEMS, INC. | CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX | 12/24/1996 |
| K955598 | CLARUS MEDICAL SYSTEMS, INC. | CLARUS SPINEPEN MODEL 2126 | 02/06/1996 |
| K200925 | Clarus Medical, LLC | Clarus Peel-Away Introducer Sheath | 03/18/2021 |
| K201308 | ClearMind Biomedical | Axonpen, Axonmonitor, Axonbox, Tablet | 11/27/2020 |
| K210251 | ClearMind Biomedical | ClearPath Disposable Introducer | 04/02/2021 |
| K982819 | ENDIUS, INC. | ENDIUS SPINE ENDOSCOPE | 01/27/1999 |
| K052745 | GEOMED MEDIZIN-TECHNIK GMBH & CO. | ASSISTO ARM SYSTEMS | 11/23/2005 |
| K222735 | HJY Smart Medical Device Co., Ltd. | HJY VisualNext Endoscopic Vision System | 07/28/2023 |
| K002330 | IMAGE-GUIDED NEUROLOGICS, INC. | NAVIGUS PEEL AWAY INTRODUCER | 10/18/2000 |
| K001630 | KARL STORZ ENDOSCOPY | KSEA BIPOLAR COAGULATING ELECTRODES | 07/19/2000 |
| K982837 | KARL STORZ ENDOSCOPY | KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS | 11/06/1998 |
| K162880 | KARL STORZ Endoscopy America, Inc | TIPCAM 1S 3D System | 03/16/2017 |
| K180146 | KARL STORZ Endoscopy America, Inc. | KARL STORZ ICG Imaging System | 04/17/2018 |
| K993539 | KARL STORZ ENDOSCOPY-AMERICA, INC. | DCI ENDOSCOPE | 12/15/1999 |
| K161112 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ Flexible Video-Neuro-Endoscope System | 09/17/2016 |
| K170462 | KARL STORZ Endoscopy-America, Inc. | KARL STORZ ShuntScope | 05/16/2017 |
| K072410 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA CLEARVISION II, MODEL 40334120 | 05/09/2008 |
| K002704 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA MINIATURE NEUROENDOSCOPE | 11/03/2000 |
| K002788 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA NEURO-FIBERSCOPE | 10/23/2000 |
| K991069 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA NEURO-FIBERSCOPE | 06/03/1999 |
| K021050 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA NEUROENDOSCOPES AND ACCESSORIES | 06/26/2002 |
| K993568 | MACHIDA ENDOSCOPE CO., LTD. | MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L | 03/13/2000 |
| K180270 | Mauna Kea Technologies | Cellvizio 100 Series Systems with Confocal Miniprobes | 05/22/2018 |
| K002572 | MEDTRONIC PS MEDICAL | MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 | 11/16/2000 |
| K990333 | MEDTRONIC PS MEDICAL | MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 | 04/28/1999 |
| K010341 | MEDTRONIC PS MEDICAL | MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, | 04/20/2001 |
| K003914 | MEDTRONIC PS MEDICAL | MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES | 02/22/2001 |
| K991989 | MITAKA USA, INC. | MITAKA POINT SETTER | 08/27/1999 |
| K181731 | MRI Interventions, Inc. | MR Compatible Aspiration Kit | 11/20/2018 |
| K961173 | NEURO NAVIGATIONAL CORP. | 1.2MM REUSABLE NEUROVIEW ENDOSCOPE | 06/07/1996 |
| K965078 | NEURO NAVIGATIONAL CORP. | 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS | 03/06/1997 |
| K961300 | NEURO NAVIGATIONAL CORP. | ASPIRATION/IRRIGATION CATHETER | 06/07/1996 |
| K960792 | NEURO NAVIGATIONAL CORP. | DISPOSABLE NEUROVIEW INTRODUCER SHEATH | 04/11/1996 |
| K954938 | NEURO NAVIGATIONAL CORP. | DISPOSABLE NEUROVIEW OPERATING SHEATH | 03/07/1996 |
| K955351 | NEURO NAVIGATIONAL CORP. | NEUROVIEW COAXIAL BIPOLAR ELECTRODE | 02/29/1996 |
| K961406 | NEURO NAVIGATIONAL CORP. | NEUROVIEW SCISSORS | 06/13/1996 |
| K043128 | OLYMPUS CORPORATION | OLYMPUS ENDOARM | 12/21/2004 |
| K013759 | OLYMPUS OPTICAL CO., LTD. | MSS-28CS-301/701 NEEDLESCOPE | 08/20/2002 |
| K971340 | OLYMPUS OPTICAL, CO. | OLYMPUS NEURO ENDOSCOPE | 07/29/1998 |
| K020507 | OLYMPUS WINTER & IBE GMBH | OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 | 10/08/2002 |
| K132931 | PENUMBRA, INC. | APOLLO SYSTEM | 01/17/2014 |
| K152699 | PENUMBRA, INC. | Apollo System | 03/17/2016 |
| K190719 | Penumbra, Inc. | Artemis Eye System | 08/30/2019 |
| K171332 | Penumbra, Inc. | Artemis Neuro Evacuation Device | 08/14/2017 |
| K191861 | Rebound Therapeutics | Aurora Surgiscope System | 12/06/2019 |
| K201840 | Rebound Therapeutics | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) | 11/04/2020 |
| K182211 | Rebound Therapeutics Corporation | Aurora Surgiscope System | 01/18/2019 |
| K022198 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 | 03/21/2003 |
| K031858 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES | 07/29/2004 |
| K970162 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | NEUROLOGICAL ENDOSCOPE | 10/29/1997 |
| K963642 | SOFAMOR DANEK USA,INC. | INCL II ENDOSCOPE | 03/18/1998 |
| K211202 | Stryker | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes | 08/06/2021 |
| K131434 | VISIONSENSE, LTD. | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | 07/16/2013 |
| K081102 | VISIONSENSE, LTD. | VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM | 05/29/2008 |
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