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).
Recent Cleared Devices (20 of 91)
Showing 20 most recent of 91 cleared devices.
| 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 |
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
