Product Code: GWG
FDA class 2
21 CFR 882.1480
Endoscope, Neurological
Neurology
The Endoscope, Neurological is a rigid or flexible optical instrument used to visually examine structures within the neurological system, such as the ventricles of the brain, enabling minimally invasive diagnostic and therapeutic procedures in neurosurgery. It is an FDA Class 2 device, requiring 510(k) premarket clearance; if the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission. The product code is GWG, regulated under 21 CFR 882.1480 in the Neurology specialty. No special flags apply to this device.
510(k)s
91
FEI Numbers
64
Registration Numbers
64
Unique Applicants
41
Years Active
32
Basic Information
- Product Code
- GWG
- Device Class
- FDA class 2
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 91 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243429 | HJY VisualNext 3D Endoscopic Vision System | May 21, 2025 | Substantially Equivalent | HJY Smart Medical Device Co., Ltd. |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Apr 09, 2025 | Substantially Equivalent | Integra LifeSciences Corporation |
| K233391 | cCeLL - In vivo | Aug 21, 2024 | Substantially Equivalent | VPIX Medical, Inc. |
| K223615 | Digital ClarusScope System, Digital NeuroPEN System | Nov 21, 2023 | Substantially Equivalent | Clarus Medical, LLC |
| K232618 | Aurora Surgiscope System | Oct 27, 2023 | Substantially Equivalent | Rebound Therapeutics Corporation |
| K230125 | Neuroblade System | Oct 13, 2023 | Substantially Equivalent | ClearMind Biomedical |
| K232159 | QEVO System | Sep 21, 2023 | Substantially Equivalent | Carl Zeiss Meditec AG |
| K222735 | HJY VisualNext Endoscopic Vision System | Jul 28, 2023 | Substantially Equivalent | HJY Smart Medical Device Co., Ltd. |
| K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes | Aug 06, 2021 | Substantially Equivalent | Stryker |
| K210251 | ClearPath Disposable Introducer | Apr 02, 2021 | Substantially Equivalent | ClearMind Biomedical |
| K200925 | Clarus Peel-Away Introducer Sheath | Mar 18, 2021 | Substantially Equivalent | Clarus Medical, LLC |
| K201308 | Axonpen, Axonmonitor, Axonbox, Tablet | Nov 27, 2020 | Substantially Equivalent | ClearMind Biomedical |
| K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) | Nov 04, 2020 | Substantially Equivalent | Rebound Therapeutics |
| K191861 | Aurora Surgiscope System | Dec 06, 2019 | Substantially Equivalent | Rebound Therapeutics |
| K190719 | Artemis Eye System | Aug 30, 2019 | Substantially Equivalent | Penumbra, Inc. |
| K182211 | Aurora Surgiscope System | Jan 18, 2019 | Substantially Equivalent | Rebound Therapeutics Corporation |
| K181731 | MR Compatible Aspiration Kit | Nov 20, 2018 | Substantially Equivalent | MRI Interventions, Inc. |
| K181116 | CONVIVO | Oct 25, 2018 | Substantially Equivalent | Carl Zeiss Meditec AG |
| K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | May 22, 2018 | Substantially Equivalent | Mauna Kea Technologies |
| K180146 | KARL STORZ ICG Imaging System | Apr 17, 2018 | Substantially Equivalent | KARL STORZ Endoscopy America, Inc. |
| K170667 | QEVO System with KINEVO 900 | Aug 18, 2017 | Substantially Equivalent | Carl Zeiss Meditec AG |
| K171332 | Artemis Neuro Evacuation Device | Aug 14, 2017 | Substantially Equivalent | Penumbra, Inc. |
| K170462 | KARL STORZ ShuntScope | May 16, 2017 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K162880 | TIPCAM 1S 3D System | Mar 16, 2017 | Substantially Equivalent | KARL STORZ Endoscopy America, Inc |
| K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | Sep 17, 2016 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K152699 | Apollo System | Mar 17, 2016 | Substantially Equivalent | PENUMBRA, INC. |
| K142315 | MINOP Disposable Introducer 26F | Nov 14, 2014 | Substantially Equivalent | AESCULAP, INC. |
| K132931 | APOLLO SYSTEM | Jan 17, 2014 | Substantially Equivalent | PENUMBRA, INC. |
| K131434 | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM | Jul 16, 2013 | Substantially Equivalent | VISIONSENSE, LTD. |
| K081102 | VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM | May 29, 2008 | Substantially Equivalent | VISIONSENSE, LTD. |
| K072410 | KSEA CLEARVISION II, MODEL 40334120 | May 09, 2008 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K061135 | MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019 | Jul 11, 2006 | Substantially Equivalent | AESCULAP |
| K052745 | ASSISTO ARM SYSTEMS | Nov 23, 2005 | Substantially Equivalent | GEOMED MEDIZIN-TECHNIK GMBH & CO. |
| K043128 | OLYMPUS ENDOARM | Dec 21, 2004 | Substantially Equivalent | OLYMPUS CORPORATION |
| K031858 | NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES | Jul 29, 2004 | Substantially Equivalent | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| K022198 | ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 | Mar 21, 2003 | Substantially Equivalent | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| K020507 | OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 | Oct 08, 2002 | Substantially Equivalent | OLYMPUS WINTER & IBE GMBH |
| K013759 | MSS-28CS-301/701 NEEDLESCOPE | Aug 20, 2002 | Substantially Equivalent | OLYMPUS OPTICAL CO., LTD. |
| K021050 | KSEA NEUROENDOSCOPES AND ACCESSORIES | Jun 26, 2002 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K014149 | PAEDISCOPE, MODEL # P010A AND PF011A | Mar 18, 2002 | Substantially Equivalent | AESCULAP, INC. |
| K010341 | MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, | Apr 20, 2001 | Substantially Equivalent | MEDTRONIC PS MEDICAL |
| K003914 | MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES | Feb 22, 2001 | Substantially Equivalent | MEDTRONIC PS MEDICAL |
| K002572 | MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 | Nov 16, 2000 | Substantially Equivalent | MEDTRONIC PS MEDICAL |
| K002704 | KSEA MINIATURE NEUROENDOSCOPE | Nov 03, 2000 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K002788 | KSEA NEURO-FIBERSCOPE | Oct 23, 2000 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K002330 | NAVIGUS PEEL AWAY INTRODUCER | Oct 18, 2000 | Substantially Equivalent | IMAGE-GUIDED NEUROLOGICS, INC. |
| K001630 | KSEA BIPOLAR COAGULATING ELECTRODES | Jul 19, 2000 | Substantially Equivalent | KARL STORZ ENDOSCOPY |
| K993568 | MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L | Mar 13, 2000 | Substantially Equivalent | MACHIDA ENDOSCOPE CO., LTD. |
| K993539 | DCI ENDOSCOPE | Dec 15, 1999 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K991989 | MITAKA POINT SETTER | Aug 27, 1999 | Substantially Equivalent | MITAKA USA, INC. |
| K991069 | KSEA NEURO-FIBERSCOPE | Jun 03, 1999 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K990333 | MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 | Apr 28, 1999 | Substantially Equivalent | MEDTRONIC PS MEDICAL |
| K982819 | ENDIUS SPINE ENDOSCOPE | Jan 27, 1999 | Substantially Equivalent | ENDIUS, INC. |
| K983365 | AESCULAP MINOP SYSTEM | Dec 18, 1998 | Substantially Equivalent | AESCULAP, INC. |
| K982837 | KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS | Nov 06, 1998 | Substantially Equivalent | KARL STORZ ENDOSCOPY |
| K971340 | OLYMPUS NEURO ENDOSCOPE | Jul 29, 1998 | Substantially Equivalent | OLYMPUS OPTICAL, CO. |
| K963642 | INCL II ENDOSCOPE | Mar 18, 1998 | Substantially Equivalent | SOFAMOR DANEK USA,INC. |
| K970162 | NEUROLOGICAL ENDOSCOPE | Oct 29, 1997 | Substantially Equivalent | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| K964281 | AESCULAP ANGLED NEUROENDOSCOPES | Apr 21, 1997 | Substantially Equivalent | AESCULAP, INC. |
| K965078 | 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS | Mar 06, 1997 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K960915 | CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX | Dec 24, 1996 | Substantially Equivalent | CLARUS MEDICAL SYSTEMS, INC. |
| K961406 | NEUROVIEW SCISSORS | Jun 13, 1996 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K961300 | ASPIRATION/IRRIGATION CATHETER | Jun 07, 1996 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K961173 | 1.2MM REUSABLE NEUROVIEW ENDOSCOPE | Jun 07, 1996 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K960792 | DISPOSABLE NEUROVIEW INTRODUCER SHEATH | Apr 11, 1996 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K954938 | DISPOSABLE NEUROVIEW OPERATING SHEATH | Mar 07, 1996 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K954394 | AESCULAP VENTRICULOSCOPE SYSTEM | Mar 07, 1996 | Substantially Equivalent | AESCULAP, INC. |
| K955351 | NEUROVIEW COAXIAL BIPOLAR ELECTRODE | Feb 29, 1996 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K955598 | CLARUS SPINEPEN MODEL 2126 | Feb 06, 1996 | Substantially Equivalent | CLARUS MEDICAL SYSTEMS, INC. |
| K954899 | RIGID NEUROVIEW ENDOSCOPE | Dec 19, 1995 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K953554 | NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES | Oct 18, 1995 | Substantially Equivalent | NOBLES-LAI ENGINEERING, INC. |
| K953685 | INSTRUMENT SCOPE | Oct 12, 1995 | Substantially Equivalent | CLARUS MEDICAL SYSTEMS, INC. |
| K953173 | NONPOWERED NEUROSURGICAL INSTRUMENT | Oct 03, 1995 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K945633 | NEURO CHANNEL ENDOSCOPE MODEL 2232 | Sep 19, 1995 | Substantially Equivalent | CLARUS MEDICAL SYSTEMS, INC. |
| K950154 | 1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES | Jul 14, 1995 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K945296 | CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 | Jul 14, 1995 | Substantially Equivalent | CLARUS MEDICAL SYSTEMS, INC. |
| K940273 | NOBLES-LAI VIDEO IMAGING SYSTEM | May 22, 1995 | Substantially Equivalent | VISIONEERING, INC. |
| K934154 | DISPOSABLE ASPIRATION/IRRIGATION CATHETER | Feb 21, 1995 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K945572 | CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352 | Feb 03, 1995 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K942413 | CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR | Nov 22, 1994 | Substantially Equivalent | CLARUS MEDICAL SYSTEMS, INC. |
| K942249 | CLARUS NEUROPEN MODEL 2120 | Nov 04, 1994 | Substantially Equivalent | CLARUS MEDICAL SYSTEMS, INC. |
| K942955 | DISPOSABLE BIPOLAR ELECTRODE | Aug 03, 1994 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K941239 | AESCULAP NEUROENDOSCOPE | Jul 11, 1994 | Substantially Equivalent | AESCULAP, INC. |
| K940096 | PS MEDICAL CATHETER PLACEMENT KIT | May 03, 1994 | Substantially Equivalent | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
| K934196 | CODMAN QUICK SHUNT KIT, CAT. #82-6570 | Apr 12, 1994 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K924977 | CODMAN LASER NEUROENDOSCOPE | Nov 22, 1993 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K931973 | DISPOSABLE PEEL-AWAY INTRODUCER SHEATH | Sep 14, 1993 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K933244 | DISPOSABLE GRASPING FORCEP | Sep 10, 1993 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K925881 | DISPOSABLE BIOPSY FORCEP | Feb 19, 1993 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K923479 | DISPOSABLE NEUROVIEW ENDOSCOPE | Feb 19, 1993 | Substantially Equivalent | NEURO NAVIGATIONAL CORP. |
| K923646 | CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS | Dec 21, 1992 | Substantially Equivalent | Codman & Shurtleff, Inc. |
FEI Numbers
This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.