GWG · Endoscope, Neurological
Neurology · 21 CFR 882.1480 · Class 2
Overview
| Product Code | GWG |
|---|---|
| Device Name | Endoscope, Neurological |
| Regulation | 21 CFR 882.1480 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.
Classification Rationale
Class II (performance standards).
Cleared Devices (91)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243429 | HJY VisualNext 3D Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | May 21, 2025 | SESE |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Integra LifeSciences Corporation | Apr 9, 2025 | SESE |
| K233391 | cCeLL - In vivo | VPIX Medical, Inc. | Aug 21, 2024 | SESE |
| K223615 | Digital ClarusScope System, Digital NeuroPEN System | Clarus Medical, LLC | Nov 21, 2023 | SESE |
| K232618 | Aurora Surgiscope System | Rebound Therapeutics Corporation | Oct 27, 2023 | SESE |
| K230125 | Neuroblade System | Clearmind Biomedical | Oct 13, 2023 | SESE |
| K232159 | QEVO System | Carl Zeiss Meditec, AG | Sep 21, 2023 | SESE |
| K222735 | HJY VisualNext Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | Jul 28, 2023 | SESE |
| K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes | Stryker | Aug 6, 2021 | SESE |
| K210251 | ClearPath Disposable Introducer | Clearmind Biomedical | Apr 2, 2021 | SESE |
| K200925 | Clarus Peel-Away Introducer Sheath | Clarus Medical, LLC | Mar 18, 2021 | SESE |
| K201308 | Axonpen, Axonmonitor, Axonbox, Tablet | Clearmind Biomedical | Nov 27, 2020 | SESE |
| K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) | Rebound Therapeutics | Nov 4, 2020 | SESE |
| K191861 | Aurora Surgiscope System | Rebound Therapeutics | Dec 6, 2019 | SESE |
| K190719 | Artemis Eye System | Penumbra, Inc. | Aug 30, 2019 | SESE |
| K182211 | Aurora Surgiscope System | Rebound Therapeutics Corporation | Jan 18, 2019 | SESE |
| K181731 | MR Compatible Aspiration Kit | Mri Interventions, Inc. | Nov 20, 2018 | SESE |
| K181116 | CONVIVO | Carl Zeiss Meditec, AG | Oct 25, 2018 | SESE |
| K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | May 22, 2018 | SESE |
| K180146 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. | Apr 17, 2018 | SESE |
| K170667 | QEVO System with KINEVO 900 | Carl Zeiss Meditec, AG | Aug 18, 2017 | SESE |
| K171332 | Artemis Neuro Evacuation Device | Penumbra, Inc. | Aug 14, 2017 | SESE |
| K170462 | KARL STORZ ShuntScope | KARL STORZ Endoscopy-America, Inc. | May 16, 2017 | SESE |
| K162880 | TIPCAM 1S 3D System | Karl Storz Endoscopy America, Inc. | Mar 16, 2017 | SESE |
| K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | KARL STORZ Endoscopy-America, Inc. | Sep 17, 2016 | SESE |
| K152699 | Apollo System | Penumbra, Inc. | Mar 17, 2016 | SESE |
| K142315 | MINOP Disposable Introducer 26F | Aesculap, Inc. | Nov 14, 2014 | SESE |
| K132931 | APOLLO SYSTEM | Penumbra, Inc. | Jan 17, 2014 | SESE |
| K131434 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Visionsense, Ltd. | Jul 16, 2013 | SESE |
| K081102 | VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM | Visionsense, Ltd. | May 29, 2008 | SESE |
| K072410 | KSEA CLEARVISION II, MODEL 40334120 | KARL STORZ Endoscopy-America, Inc. | May 9, 2008 | SESE |
| K061135 | MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019 | Aesculap | Jul 11, 2006 | SESE |
| K052745 | ASSISTO ARM SYSTEMS | Geomed Medizin-Technik GmbH & Co. | Nov 23, 2005 | SESE |
| K043128 | OLYMPUS ENDOARM | Olympus Corporation | Dec 21, 2004 | SESE |
| K031858 | NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES | Richard Wolf Medical Instruments Corp. | Jul 29, 2004 | SESE |
| K022198 | ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 | Richard Wolf Medical Instruments Corp. | Mar 21, 2003 | SESE |
| K020507 | OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 | Olympus Winter & Ibe GmbH | Oct 8, 2002 | SESE |
| K013759 | MSS-28CS-301/701 NEEDLESCOPE | Olympus Optical Co., Ltd. | Aug 20, 2002 | SESE |
| K021050 | KSEA NEUROENDOSCOPES AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | Jun 26, 2002 | SESE |
| K014149 | PAEDISCOPE, MODEL # P010A AND PF011A | Aesculap, Inc. | Mar 18, 2002 | SESE |
| K010341 | MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, | Medtronic PS Medical | Apr 20, 2001 | SESE |
| K003914 | MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES | Medtronic PS Medical | Feb 22, 2001 | SESE |
| K002572 | MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 | Medtronic PS Medical | Nov 16, 2000 | SESE |
| K002704 | KSEA MINIATURE NEUROENDOSCOPE | KARL STORZ Endoscopy-America, Inc. | Nov 3, 2000 | SESE |
| K002788 | KSEA NEURO-FIBERSCOPE | KARL STORZ Endoscopy-America, Inc. | Oct 23, 2000 | SESE |
| K002330 | NAVIGUS PEEL AWAY INTRODUCER | Image-Guided Neurologics, Inc. | Oct 18, 2000 | SESE |
| K001630 | KSEA BIPOLAR COAGULATING ELECTRODES | Karl Storz Endoscopy | Jul 19, 2000 | SESE |
| K993568 | MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L | Machida Endoscope Co., Ltd. | Mar 13, 2000 | SESE |
| K993539 | DCI ENDOSCOPE | KARL STORZ Endoscopy-America, Inc. | Dec 15, 1999 | SESE |
| K991989 | MITAKA POINT SETTER | Mitaka USA, Inc. | Aug 27, 1999 | SESE |
| K991069 | KSEA NEURO-FIBERSCOPE | KARL STORZ Endoscopy-America, Inc. | Jun 3, 1999 | SESE |
| K990333 | MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 | Medtronic PS Medical | Apr 28, 1999 | SESE |
| K982819 | ENDIUS SPINE ENDOSCOPE | Endius, Inc. | Jan 27, 1999 | SESE |
| K983365 | AESCULAP MINOP SYSTEM | Aesculap, Inc. | Dec 18, 1998 | SESE |
| K982837 | KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS | Karl Storz Endoscopy | Nov 6, 1998 | SESE |
| K971340 | OLYMPUS NEURO ENDOSCOPE | Olympus Optical, Co. | Jul 29, 1998 | SESE |
| K963642 | INCL II ENDOSCOPE | Sofamor Danek USA,Inc. | Mar 18, 1998 | SESE |
| K970162 | NEUROLOGICAL ENDOSCOPE | Richard Wolf Medical Instruments Corp. | Oct 29, 1997 | SESE |
| K964281 | AESCULAP ANGLED NEUROENDOSCOPES | Aesculap, Inc. | Apr 21, 1997 | SESE |
| K965078 | 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS | Neuro Navigational Corp. | Mar 6, 1997 | SESE |
| K960915 | CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX | Clarus Medical Systems, Inc. | Dec 24, 1996 | SESE |
| K961406 | NEUROVIEW SCISSORS | Neuro Navigational Corp. | Jun 13, 1996 | SESE |
| K961300 | ASPIRATION/IRRIGATION CATHETER | Neuro Navigational Corp. | Jun 7, 1996 | SESE |
| K961173 | 1.2MM REUSABLE NEUROVIEW ENDOSCOPE | Neuro Navigational Corp. | Jun 7, 1996 | SESE |
| K960792 | DISPOSABLE NEUROVIEW INTRODUCER SHEATH | Neuro Navigational Corp. | Apr 11, 1996 | SESE |
| K954938 | DISPOSABLE NEUROVIEW OPERATING SHEATH | Neuro Navigational Corp. | Mar 7, 1996 | SESE |
| K954394 | AESCULAP VENTRICULOSCOPE SYSTEM | Aesculap, Inc. | Mar 7, 1996 | SESE |
| K955351 | NEUROVIEW COAXIAL BIPOLAR ELECTRODE | Neuro Navigational Corp. | Feb 29, 1996 | SESE |
| K955598 | CLARUS SPINEPEN MODEL 2126 | Clarus Medical Systems, Inc. | Feb 6, 1996 | SESE |
| K954899 | RIGID NEUROVIEW ENDOSCOPE | Neuro Navigational Corp. | Dec 19, 1995 | SESE |
| K953554 | NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES | Nobles-Lai Engineering, Inc. | Oct 18, 1995 | SESE |
| K953685 | INSTRUMENT SCOPE | Clarus Medical Systems, Inc. | Oct 12, 1995 | SESE |
| K953173 | NONPOWERED NEUROSURGICAL INSTRUMENT | United States Surgical, A Division of Tyco Healthc | Oct 3, 1995 | SESE |
| K945633 | NEURO CHANNEL ENDOSCOPE MODEL 2232 | Clarus Medical Systems, Inc. | Sep 19, 1995 | SESE |
| K950154 | 1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES | Neuro Navigational Corp. | Jul 14, 1995 | SESE |
| K945296 | CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 | Clarus Medical Systems, Inc. | Jul 14, 1995 | SESE |
| K940273 | NOBLES-LAI VIDEO IMAGING SYSTEM | Visioneering, Inc. | May 22, 1995 | SESE |
| K934154 | DISPOSABLE ASPIRATION/IRRIGATION CATHETER | Neuro Navigational Corp. | Feb 21, 1995 | SESE |
| K945572 | CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352 | Johnson & Johnson Professionals, Inc. | Feb 3, 1995 | SESE |
| K942413 | CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR | Clarus Medical Systems, Inc. | Nov 22, 1994 | SESE |
| K942249 | CLARUS NEUROPEN MODEL 2120 | Clarus Medical Systems, Inc. | Nov 4, 1994 | SESE |
| K942955 | DISPOSABLE BIPOLAR ELECTRODE | Neuro Navigational Corp. | Aug 3, 1994 | SESE |
| K941239 | AESCULAP NEUROENDOSCOPE | Aesculap, Inc. | Jul 11, 1994 | SESE |
| K940096 | PS MEDICAL CATHETER PLACEMENT KIT | Pudenz-Schulte Medical Research Corp. | May 3, 1994 | SESE |
| K934196 | CODMAN QUICK SHUNT KIT, CAT. #82-6570 | Codman & Shurtleff, Inc. | Apr 12, 1994 | SESE |
| K924977 | CODMAN LASER NEUROENDOSCOPE | Codman & Shurtleff, Inc. | Nov 22, 1993 | SESE |
| K931973 | DISPOSABLE PEEL-AWAY INTRODUCER SHEATH | Neuro Navigational Corp. | Sep 14, 1993 | SESE |
| K933244 | DISPOSABLE GRASPING FORCEP | Neuro Navigational Corp. | Sep 10, 1993 | SESE |
| K925881 | DISPOSABLE BIOPSY FORCEP | Neuro Navigational Corp. | Feb 19, 1993 | SESE |
| K923479 | DISPOSABLE NEUROVIEW ENDOSCOPE | Neuro Navigational Corp. | Feb 19, 1993 | SESE |
| K923646 | CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS | Codman & Shurtleff, Inc. | Dec 21, 1992 | SESE |
Top Applicants
- Neuro Navigational Corp. — 15 clearances
- KARL STORZ Endoscopy-America, Inc. — 8 clearances
- Clarus Medical Systems, Inc. — 7 clearances
- Aesculap, Inc. — 6 clearances
- Penumbra, Inc. — 4 clearances
