Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1480](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1480) → GWG — Endoscope, Neurological # GWG · Endoscope, Neurological _Neurology · 21 CFR 882.1480 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG ## Overview - **Product Code:** GWG - **Device Name:** Endoscope, Neurological - **Regulation:** [21 CFR 882.1480](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1480) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## 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). ## Recent Cleared Devices (20 of 91) Showing 20 most recent of 91 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243429](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K243429.md) | HJY VisualNext 3D Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | May 21, 2025 | SESE | | [K250752](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K250752.md) | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Integra LifeSciences Corporation | Apr 9, 2025 | SESE | | [K233391](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K233391.md) | cCeLL - In vivo | VPIX Medical, Inc. | Aug 21, 2024 | SESE | | [K223615](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K223615.md) | Digital ClarusScope System, Digital NeuroPEN System | Clarus Medical, LLC | Nov 21, 2023 | SESE | | [K232618](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K232618.md) | Aurora Surgiscope System | Rebound Therapeutics Corporation | Oct 27, 2023 | SESE | | [K230125](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K230125.md) | Neuroblade System | Clearmind Biomedical | Oct 13, 2023 | SESE | | [K232159](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K232159.md) | QEVO System | Carl Zeiss Meditec, AG | Sep 21, 2023 | SESE | | [K222735](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K222735.md) | HJY VisualNext Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | Jul 28, 2023 | SESE | | [K211202](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K211202.md) | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes | Stryker | Aug 6, 2021 | SESE | | [K210251](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K210251.md) | ClearPath Disposable Introducer | Clearmind Biomedical | Apr 2, 2021 | SESE | | [K200925](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K200925.md) | Clarus Peel-Away Introducer Sheath | Clarus Medical, LLC | Mar 18, 2021 | SESE | | [K201308](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K201308.md) | Axonpen, Axonmonitor, Axonbox, Tablet | Clearmind Biomedical | Nov 27, 2020 | SESE | | [K201840](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K201840.md) | Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) | Rebound Therapeutics | Nov 4, 2020 | SESE | | [K191861](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K191861.md) | Aurora Surgiscope System | Rebound Therapeutics | Dec 6, 2019 | SESE | | [K190719](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K190719.md) | Artemis Eye System | Penumbra, Inc. | Aug 30, 2019 | SESE | | [K182211](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K182211.md) | Aurora Surgiscope System | Rebound Therapeutics Corporation | Jan 18, 2019 | SESE | | [K181731](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K181731.md) | MR Compatible Aspiration Kit | Mri Interventions, Inc. | Nov 20, 2018 | SESE | | [K181116](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K181116.md) | CONVIVO | Carl Zeiss Meditec, AG | Oct 25, 2018 | SESE | | [K180270](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K180270.md) | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | May 22, 2018 | SESE | | [K180146](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG/K180146.md) | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. | Apr 17, 2018 | 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 - Medtronic PS Medical — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GWG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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