GWG
- Product code
- GWG
- Device name
- Endoscope, Neurological
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1480
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 93
FDA classification 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) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253602 | 2026-06-04 | Stryker Endoscopy | Precision S 4K Sinuscope | |
| K253679 | 2026-05-08 | Stryker Instruments | Hydro Irrigation System | |
| K243429 | 2025-05-21 | Hjy Smart Medical Device Co., Ltd. | HJY VisualNext 3D Endoscopic Vision System | |
| K250752 | 2025-04-09 | Integra LifeSciences Corporation | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgi | |
| K233391 | 2024-08-21 | VPIX Medical, Inc. | cCeLL - In vivo | |
| K223615 | 2023-11-21 | Clarus Medical, LLC | Digital ClarusScope System, Digital NeuroPEN System | |
| K232618 | 2023-10-27 | Rebound Therapeutics Corporation | Aurora Surgiscope System | |
| K230125 | 2023-10-13 | Clearmind Biomedical | Neuroblade System | |
| K232159 | 2023-09-21 | Carl Zeiss Meditec, AG | QEVO System |
Official FDA classification page: GWG
Classification and pathway per current FDA publications. Data from openFDA (CC0).