Endoscope, Neurological
FDA product code GWG · Class II (moderate risk) · 21 CFR 882.1480 · Neurology
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).
93510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Neuro Navigational Corp. 15
- KARL STORZ Endoscopy-America, Inc. 10
- Aesculap, Inc. 7
- Clarus Medical Systems, Inc. 7
- Penumbra, Inc. 4
- Rebound Therapeutics 4
- Medtronic PS Medical 4
- Codman & Shurtleff, Inc. 3
- Carl Zeiss Meditec, AG 3
- Richard Wolf Medical Instruments Corp. 3
- Clearmind Biomedical 3
- Visionsense, Ltd. 2
- Hjy Smart Medical Device Co., Ltd. 2
- Karl Storz Endoscopy 2
- The Olympus Optical Co. 2
- Clarus Medical, LLC 2
- Sofamor Danek USA,Inc. 1
- Stryker Endoscopy 1
- United States Surgical, A Division of Tyco Healthc 1
- Johnson & Johnson Professionals, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253602 | Precision S 4K SinuscopeGWG · Traditional | Stryker Endoscopy | 06/04/2026SE |
| K253679 | Hydro Irrigation SystemGWG · Traditional | Stryker Instruments | 05/08/2026SE |
| K243429 | HJY VisualNext 3D Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 05/21/2025SE |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | Integra LifeSciences Corporation | 04/09/2025SE |
| K233391 | cCeLL - In vivoGWG · Traditional | VPIX Medical, Inc. | 08/21/2024SE |
| K223615 | Digital ClarusScope System, Digital NeuroPEN SystemGWG · Traditional | Clarus Medical, LLC | 11/21/2023SE |
| K232618 | Aurora Surgiscope SystemGWG · Traditional | Rebound Therapeutics Corporation | 10/27/2023SE |
| K230125 | Neuroblade SystemGWG · Traditional | Clearmind Biomedical | 10/13/2023SE |
| K232159 | QEVO SystemGWG · Special | Carl Zeiss Meditec, AG | 09/21/2023SE |
| K222735 | HJY VisualNext Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 07/28/2023SE |
| K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…GWG · Traditional | Stryker | 08/06/2021SE |
| K210251 | ClearPath Disposable IntroducerGWG · Traditional | Clearmind Biomedical | 04/02/2021SE |
| K200925 | Clarus Peel-Away Introducer SheathGWG · Traditional | Clarus Medical, LLC | 03/18/2021SE |
| K201308 | Axonpen, Axonmonitor, Axonbox, TabletGWG · Traditional | Clearmind Biomedical | 11/27/2020SE |
| K201840 | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)GWG · Traditional | Rebound Therapeutics | 11/04/2020SE |
| K191861 | Aurora Surgiscope SystemGWG · Traditional | Rebound Therapeutics | 12/06/2019SE |
| K190719 | Artemis Eye SystemGWG · Traditional | Penumbra, Inc. | 08/30/2019SE |
| K182211 | Aurora Surgiscope SystemGWG · Traditional | Rebound Therapeutics Corporation | 01/18/2019SE |
| K181731 | MR Compatible Aspiration KitGWG · Traditional | Mri Interventions, Inc. | 11/20/2018SE |
| K181116 | ConvivoGWG · Traditional | Carl Zeiss Meditec, AG | 10/25/2018SE |
| K180270 | Cellvizio 100 Series Systems with Confocal MiniprobesGWG · Traditional | Mauna Kea Technologies | 05/22/2018SE |
| K180146 | KARL STORZ ICG Imaging SystemGWG · Traditional | Karl Storz Endoscopy America, Inc. | 04/17/2018SE |
| K170667 | QEVO System with KINEVO 900GWG · Traditional | Carl Zeiss Meditec, AG | 08/18/2017SE |
| K171332 | Artemis Neuro Evacuation DeviceGWG · Traditional | Penumbra, Inc. | 08/14/2017SE |
| K170462 | KARL STORZ ShuntScopeGWG · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/16/2017SE |
| K162880 | TIPCAM 1S 3D SystemGWG · Traditional | Karl Storz Endoscopy America, Inc. | 03/16/2017SE |
| K161112 | KARL STORZ Flexible Video-Neuro-Endoscope SystemGWG · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/17/2016SE |
| K152699 | Apollo SystemGWG · Traditional | Penumbra, Inc. | 03/17/2016SE |
| K142315 | MINOP Disposable Introducer 26FGWG · Special | Aesculap, Inc. | 11/14/2014SE |
| K132931 | Apollo SystemGWG · Traditional | Penumbra, Inc. | 01/17/2014SE |
| K131434 | VS3 Stereoscopic High Definition Vision SystemGWG · Special | Visionsense, Ltd. | 07/16/2013SE |
| K081102 | Vsu - Visionsense Stereoscopic Vision SystemGWG · Traditional | Visionsense, Ltd. | 05/29/2008SE |
| K072410 | Ksea Clearvision II, Model 40334120GWG · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/09/2008SE |
| K061135 | Minop Disposable Introducer 10F, Model ME010; 19F, Model ME019GWG · Traditional | Aesculap | 07/11/2006SE |
| K052745 | Assisto Arm SystemsGWG · Traditional | Geomed Medizin-Technik GmbH & Co. | 11/23/2005SE |
| K043128 | Olympus EndoarmGWG · Traditional | Olympus Corporation | 12/21/2004SE |
| K031858 | Neuro-Endoscope System by Hopf, Existing of: Endoscopes, Sheaths, Working Elements…GWG · Traditional | Richard Wolf Medical Instruments Corp. | 07/29/2004SE |
| K022198 | Endoscope Set for Magnetic Resonance (MR), Models 8767.412, 8767.121 & 8767.452GWG · Traditional | Richard Wolf Medical Instruments Corp. | 03/21/2003SE |
| K020507 | Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 and S-1349/4GWG · Traditional | Olympus Winter & Ibe GmbH | 10/08/2002SE |
| K013759 | MSS-28CS-301/701 NeedlescopeGWG · Traditional | Olympus Optical Co., Ltd. | 08/20/2002SE |
| K021050 | Ksea Neuroendoscopes and AccessoriesGWG · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/26/2002SE |
| K014149 | Paediscope, Model # P010A and PF011AGWG · Traditional | Aesculap, Inc. | 03/18/2002SE |
| K010341 | Medtronic PS Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157…GWG · Abbreviated | Medtronic PS Medical | 04/20/2001SE |
| K003914 | Medtronic PS Medical Neuropen Endoscope and Optical AccessoriesGWG · Abbreviated | Medtronic PS Medical | 02/22/2001SE |
| K002572 | Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003…GWG · Abbreviated | Medtronic PS Medical | 11/16/2000SE |
| K002704 | Ksea Miniature NeuroendoscopeGWG · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/03/2000SE |
| K002788 | Ksea Neuro-FiberscopeGWG · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/23/2000SE |
| K002330 | Navigus Peel Away IntroducerGWG · Traditional | Image-Guided Neurologics, Inc. | 10/18/2000SE |
| K001630 | Ksea Bipolar Coagulating ElectrodesGWG · Traditional | Karl Storz Endoscopy | 07/19/2000SE |
| K993568 | Machida Flexible Neuro-Endoscope, Models NEU-4, NEU-4LGWG · Traditional | Machida Endoscope Co., Ltd. | 03/13/2000SE |
| K993539 | Dci EndoscopeGWG · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/15/1999SE |
| K991989 | Mitaka Point SetterGWG · Traditional | Mitaka USA, Inc. | 08/27/1999SE |
| K991069 | Ksea Neuro-FiberscopeGWG · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/03/1999SE |
| K990333 | Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015GWG · Traditional | Medtronic PS Medical | 04/28/1999SE |
| K982819 | Endius Spine EndoscopeGWG · Traditional | Endius, Inc. | 01/27/1999SE |
| K983365 | Aesculap Minop SystemGWG · Traditional | Aesculap, Inc. | 12/18/1998SE |
| K982837 | Ksea Gaab Neuroendoscope and Chavantes-Zaamorano Neuroendoscope SetsGWG · Traditional | Karl Storz Endoscopy | 11/06/1998SE |
| K971340 | Olympus Neuro EndoscopeGWG · Traditional | Olympus Optical, Co. | 07/29/1998SE |
| K963642 | Incl II EndoscopeGWG · Traditional | Sofamor Danek USA,Inc. | 03/18/1998SE |
| K970162 | Neurological EndoscopeGWG · Traditional | Richard Wolf Medical Instruments Corp. | 10/29/1997SE |
| K964281 | Aesculap Angled NeuroendoscopesGWG · Traditional | Aesculap, Inc. | 04/21/1997SE |
| K965078 | 2.1MM Semi-Rigid Neuroview SCISSORS/2.0OMM Semi-Rigid Neuroview Grasping ForcepsGWG · Traditional | Neuro Navigational Corp. | 03/06/1997SE |
| K960915 | Clarus Neuropen Endoscopic Placement Kit Model 2125-XXXGWG · Traditional | Clarus Medical Systems, Inc. | 12/24/1996SE |
| K961406 | Neuroview ScissorsGWG · Traditional | Neuro Navigational Corp. | 06/13/1996SE |
| K961300 | Aspiration/Irrigation CatheterGWG · Traditional | Neuro Navigational Corp. | 06/07/1996SE |
| K961173 | 1.2MM Reusable Neuroview EndoscopeGWG · Traditional | Neuro Navigational Corp. | 06/07/1996SE |
| K960792 | Disposable Neuroview Introducer SheathGWG · Traditional | Neuro Navigational Corp. | 04/11/1996SE |
| K954938 | Disposable Neuroview Operating SheathGWG · Traditional | Neuro Navigational Corp. | 03/07/1996SE |
| K954394 | Aesculap Ventriculoscope SystemGWG · Traditional | Aesculap, Inc. | 03/07/1996SE |
| K955351 | Neuroview Coaxial Bipolar ElectrodeGWG · Traditional | Neuro Navigational Corp. | 02/29/1996SE |
| K955598 | Clarus Spinepen Model 2126GWG · Traditional | Clarus Medical Systems, Inc. | 02/06/1996SE |
| K954899 | Rigid Neuroview EndoscopeGWG · Traditional | Neuro Navigational Corp. | 12/19/1995SE |
| K953554 | Noblescope Neuroendoscope System & AccessoriesGWG · Traditional | Nobles-Lai Engineering, Inc. | 10/18/1995SE |
| K953685 | Instrument ScopeGWG · Traditional | Clarus Medical Systems, Inc. | 10/12/1995SE |
| K953173 | Nonpowered Neurosurgical InstrumentGWG · Traditional | United States Surgical, A Division of Tyco Healthc | 10/03/1995SE |
| K945633 | Neuro Channel Endoscope Model 2232GWG · Traditional | Clarus Medical Systems, Inc. | 09/19/1995SE |
| K950154 | 1.2MM Disposable Neuroview(Tm) Performed Endoscope and AccessoriesGWG · Traditional | Neuro Navigational Corp. | 07/14/1995SE |
| K945296 | Clarus Phoenix Neuro Endoscope Model 2160GWG · Traditional | Clarus Medical Systems, Inc. | 07/14/1995SE |
| K940273 | Nobles-Lai Video Imaging SystemGWG · Traditional | Visioneering, Inc. | 05/22/1995SE |
| K934154 | Disposable Aspiration/Irrigation CatheterGWG · Traditional | Neuro Navigational Corp. | 02/21/1995SE |
| K945572 | Codman(R) Ridig and Steerable Endoscope Holder, Model 83-1352GWG · Traditional | Johnson & Johnson Professionals, Inc. | 02/03/1995SE |
| K942413 | Clarus Endoscopic Neurological Tissue ElevatorGWG · Traditional | Clarus Medical Systems, Inc. | 11/22/1994SE |
| K942249 | Clarus Neuropen Model 2120GWG · Traditional | Clarus Medical Systems, Inc. | 11/04/1994SE |
| K942955 | Disposable Bipolar ElectrodeGWG · Traditional | Neuro Navigational Corp. | 08/03/1994SE |
| K941239 | Aesculap NeuroendoscopeGWG · Traditional | Aesculap, Inc. | 07/11/1994SE |
| K940096 | PS Medical Catheter Placement KitGWG · Traditional | Pudenz-Schulte Medical Research Corp. | 05/03/1994SE |
| K934196 | Codman Quick Shunt Kit, Cat. #82-6570GWG · Traditional | Codman & Shurtleff, Inc. | 04/12/1994SE |
| K924977 | Codman Laser NeuroendoscopeGWG · Traditional | Codman & Shurtleff, Inc. | 11/22/1993SE |
| K931973 | Disposable Peel-Away Introducer SheathGWG · Traditional | Neuro Navigational Corp. | 09/14/1993SE |
| K933244 | Disposable Grasping ForcepGWG · Traditional | Neuro Navigational Corp. | 09/10/1993SE |
| K925881 | Disposable Biopsy ForcepGWG · Traditional | Neuro Navigational Corp. | 02/19/1993SE |
| K923479 | Disposable Neuroview EndoscopeGWG · Traditional | Neuro Navigational Corp. | 02/19/1993SE |
| K923646 | Codman Endoflex Grasping and Biopsy ForcepsGWG · Traditional | Codman & Shurtleff, Inc. | 12/21/1992SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1485-2026 Class II | Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog…There is the potential for the length of the trocar shaft to be too long. | Aesculap Inc | 01/15/2026Open, Classified |
| Z-1295-2025 Class II | AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator…Possibility for the obturator to break (separate). | Integra LifeSciences Corp. | 02/06/2025Open, Classified |
| Z-2331-2024 Class II | AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator…Potential sheath damage that could lead to tissue damage and/or track hemorrhage. | Integra LifeSciences Corp. | 06/07/2024Open, Classified |
| Z-2518-2023 Class II | For intraventricular indications mainly used for operations within the brain ventricles.…Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result… | Aesculap Implant Systems LLC | 07/20/2023Open, Classified |
| Z-1532-2020 Class II | Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1During a complaint investigation it was determined that an error was observed within the instruction manual… | Karl Storz Endoscopy | 08/27/2019Open, Classified |
| Z-1531-2020 Class II | Karl Storz, Model # 11161C2, Flexible NeuroscopeDuring a complaint investigation it was determined that an error was observed within the instruction manual… | Karl Storz Endoscopy | 08/27/2019Open, Classified |
| Z-1530-2020 Class II | Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric NeuroscopeDuring a complaint investigation it was determined that an error was observed within the instruction manual… | Karl Storz Endoscopy | 08/27/2019Open, Classified |
| Z-2425-2019 Class II | FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port. | Karl Storz Endoscopy | 02/20/2019Terminated |
| Z-1814-2017 Class II | AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent…Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on… | Aesculap Implant Systems LLC | 03/07/2017Terminated |
| Z-1061-2012 | ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of…The product may fracture during surgical procedures. | Geomed Medizin-Technik Gmbh & Co. | 12/16/2011Terminated |
| Z-1192-2012 | Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and…A complaint was received and a unit returned that exhibited the metal and glass shaft window becoming… | Visionsense, Ltd. | 03/21/2011Terminated |
| Z-1539-2012 | Mitaka Point Setter, holding system for surgical instruments. Holding surgical…Use of a potentially weaker spring in the device than required to meet specifications to hold the Point… | Mitaka USA, Inc. | 02/27/2009Terminated |