Atlas FDA

GWG

93 FDA 510(k) clearances · Product code

118 daysmedian time to decision
322 days90th percentile
93clearances measured

FDA profile

Official device name
Endoscope, Neurological
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1480
Medical specialty
Neurology
FDA 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).
Adverse events (MAUDE)
2016: 25 · 2017: 12 · 2018: 16 · 2020: 19 · 2021: 21 · 2025: 33
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Precision S 4K Sinuscope (K253602)Stryker Endoscopy2026-06-04
Hydro Irrigation System (K253679)Stryker Instruments2026-05-08
HJY VisualNext 3D Endoscopic Vision System (K243429)Hjy Smart Medical Device Co., Ltd.2025-05-21
AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) (K250752)Integra LifeSciences Corporation2025-04-09
cCeLL - In vivo (K233391)VPIX Medical, Inc.2024-08-21
Digital ClarusScope System, Digital NeuroPEN System (K223615)Clarus Medical, LLC2023-11-21
Aurora Surgiscope System (K232618)Rebound Therapeutics Corporation2023-10-27
Neuroblade System (K230125)Clearmind Biomedical2023-10-13
QEVO System (K232159)Carl Zeiss Meditec, AG2023-09-21
HJY VisualNext Endoscopic Vision System (K222735)Hjy Smart Medical Device Co., Ltd.2023-07-28
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes (K211202)Stryker2021-08-06
ClearPath Disposable Introducer (K210251)Clearmind Biomedical2021-04-02
Clarus Peel-Away Introducer Sheath (K200925)Clarus Medical, LLC2021-03-18
Axonpen, Axonmonitor, Axonbox, Tablet (K201308)Clearmind Biomedical2020-11-27
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) (K201840)Rebound Therapeutics2020-11-04
Aurora Surgiscope System (K191861)Rebound Therapeutics2019-12-06
Artemis Eye System (K190719)Penumbra, Inc.2019-08-30
Aurora Surgiscope System (K182211)Rebound Therapeutics Corporation2019-01-18
MR Compatible Aspiration Kit (K181731)Mri Interventions, Inc.2018-11-20
CONVIVO (K181116)Carl Zeiss Meditec, AG2018-10-25
Cellvizio 100 Series Systems with Confocal Miniprobes (K180270)Mauna Kea Technologies2018-05-22
KARL STORZ ICG Imaging System (K180146)Karl Storz Endoscopy America, Inc.2018-04-17
QEVO System with KINEVO 900 (K170667)Carl Zeiss Meditec, AG2017-08-18
Artemis Neuro Evacuation Device (K171332)Penumbra, Inc.2017-08-14
KARL STORZ ShuntScope (K170462)KARL STORZ Endoscopy-America, Inc.2017-05-16
TIPCAM 1S 3D System (K162880)Karl Storz Endoscopy America, Inc.2017-03-16
KARL STORZ Flexible Video-Neuro-Endoscope System (K161112)KARL STORZ Endoscopy-America, Inc.2016-09-17
Apollo System (K152699)Penumbra, Inc.2016-03-17
MINOP Disposable Introducer 26F (K142315)Aesculap, Inc.2014-11-14
APOLLO SYSTEM (K132931)Penumbra, Inc.2014-01-17
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM (K131434)Visionsense, Ltd.2013-07-16
VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM (K081102)Visionsense, Ltd.2008-05-29
KSEA CLEARVISION II, MODEL 40334120 (K072410)KARL STORZ Endoscopy-America, Inc.2008-05-09
MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019 (K061135)Aesculap2006-07-11
ASSISTO ARM SYSTEMS (K052745)Geomed Medizin-Technik GmbH & Co.2005-11-23
OLYMPUS ENDOARM (K043128)Olympus Corporation2004-12-21
NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES (K031858)Richard Wolf Medical Instruments Corp.2004-07-29
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 (K022198)Richard Wolf Medical Instruments Corp.2003-03-21
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 (K020507)Olympus Winter & Ibe GmbH2002-10-08
MSS-28CS-301/701 NEEDLESCOPE (K013759)Olympus Optical Co., Ltd.2002-08-20
KSEA NEUROENDOSCOPES AND ACCESSORIES (K021050)KARL STORZ Endoscopy-America, Inc.2002-06-26
PAEDISCOPE, MODEL # P010A AND PF011A (K014149)Aesculap, Inc.2002-03-18
MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, (K010341)Medtronic PS Medical2001-04-20
MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES (K003914)Medtronic PS Medical2001-02-22
MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 (K002572)Medtronic PS Medical2000-11-16
KSEA MINIATURE NEUROENDOSCOPE (K002704)KARL STORZ Endoscopy-America, Inc.2000-11-03
KSEA NEURO-FIBERSCOPE (K002788)KARL STORZ Endoscopy-America, Inc.2000-10-23
NAVIGUS PEEL AWAY INTRODUCER (K002330)Image-Guided Neurologics, Inc.2000-10-18
KSEA BIPOLAR COAGULATING ELECTRODES (K001630)Karl Storz Endoscopy2000-07-19
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L (K993568)Machida Endoscope Co., Ltd.2000-03-13
DCI ENDOSCOPE (K993539)KARL STORZ Endoscopy-America, Inc.1999-12-15
MITAKA POINT SETTER (K991989)Mitaka USA, Inc.1999-08-27
KSEA NEURO-FIBERSCOPE (K991069)KARL STORZ Endoscopy-America, Inc.1999-06-03
MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 (K990333)Medtronic PS Medical1999-04-28
ENDIUS SPINE ENDOSCOPE (K982819)Endius, Inc.1999-01-27
AESCULAP MINOP SYSTEM (K983365)Aesculap, Inc.1998-12-18
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS (K982837)Karl Storz Endoscopy1998-11-06
OLYMPUS NEURO ENDOSCOPE (K971340)Olympus Optical, Co.1998-07-29
INCL II ENDOSCOPE (K963642)Sofamor Danek USA,Inc.1998-03-18
NEUROLOGICAL ENDOSCOPE (K970162)Richard Wolf Medical Instruments Corp.1997-10-29
AESCULAP ANGLED NEUROENDOSCOPES (K964281)Aesculap, Inc.1997-04-21
2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS (K965078)Neuro Navigational Corp.1997-03-06
CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX (K960915)Clarus Medical Systems, Inc.1996-12-24
NEUROVIEW SCISSORS (K961406)Neuro Navigational Corp.1996-06-13
ASPIRATION/IRRIGATION CATHETER (K961300)Neuro Navigational Corp.1996-06-07
1.2MM REUSABLE NEUROVIEW ENDOSCOPE (K961173)Neuro Navigational Corp.1996-06-07
DISPOSABLE NEUROVIEW INTRODUCER SHEATH (K960792)Neuro Navigational Corp.1996-04-11
DISPOSABLE NEUROVIEW OPERATING SHEATH (K954938)Neuro Navigational Corp.1996-03-07
AESCULAP VENTRICULOSCOPE SYSTEM (K954394)Aesculap, Inc.1996-03-07
NEUROVIEW COAXIAL BIPOLAR ELECTRODE (K955351)Neuro Navigational Corp.1996-02-29
CLARUS SPINEPEN MODEL 2126 (K955598)Clarus Medical Systems, Inc.1996-02-06
RIGID NEUROVIEW ENDOSCOPE (K954899)Neuro Navigational Corp.1995-12-19
NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES (K953554)Nobles-Lai Engineering, Inc.1995-10-18
INSTRUMENT SCOPE (K953685)Clarus Medical Systems, Inc.1995-10-12
NONPOWERED NEUROSURGICAL INSTRUMENT (K953173)United States Surgical, A Division of Tyco Healthc1995-10-03
NEURO CHANNEL ENDOSCOPE MODEL 2232 (K945633)Clarus Medical Systems, Inc.1995-09-19
1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES (K950154)Neuro Navigational Corp.1995-07-14
CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 (K945296)Clarus Medical Systems, Inc.1995-07-14
NOBLES-LAI VIDEO IMAGING SYSTEM (K940273)Visioneering, Inc.1995-05-22
DISPOSABLE ASPIRATION/IRRIGATION CATHETER (K934154)Neuro Navigational Corp.1995-02-21
CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352 (K945572)Johnson & Johnson Professionals, Inc.1995-02-03
CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR (K942413)Clarus Medical Systems, Inc.1994-11-22
CLARUS NEUROPEN MODEL 2120 (K942249)Clarus Medical Systems, Inc.1994-11-04
DISPOSABLE BIPOLAR ELECTRODE (K942955)Neuro Navigational Corp.1994-08-03
AESCULAP NEUROENDOSCOPE (K941239)Aesculap, Inc.1994-07-11
PS MEDICAL CATHETER PLACEMENT KIT (K940096)Pudenz-Schulte Medical Research Corp.1994-05-03
CODMAN QUICK SHUNT KIT, CAT. #82-6570 (K934196)Codman & Shurtleff, Inc.1994-04-12
CODMAN LASER NEUROENDOSCOPE (K924977)Codman & Shurtleff, Inc.1993-11-22
DISPOSABLE PEEL-AWAY INTRODUCER SHEATH (K931973)Neuro Navigational Corp.1993-09-14
DISPOSABLE GRASPING FORCEP (K933244)Neuro Navigational Corp.1993-09-10
DISPOSABLE NEUROVIEW ENDOSCOPE (K923479)Neuro Navigational Corp.1993-02-19
DISPOSABLE BIOPSY FORCEP (K925881)Neuro Navigational Corp.1993-02-19
CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS (K923646)Codman & Shurtleff, Inc.1992-12-21

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