K243429
- 510(k) number
- K243429
- Device name
- HJY VisualNext 3D Endoscopic Vision System
- Applicant
- Hjy Smart Medical Device Co., Ltd. TW
- Product code
- GWG — Endoscope, Neurological
- Decision date
- 2025-05-21
- Date received
- 2024-11-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243429.pdf
Official FDA record: K243429
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.