HJY VisualNext 3D Endoscopic Vision System— 510(k) K243429
Substantially EquivalentHjy Smart Medical Device Co., Ltd.
FDA 510(k) clearance K243429 for HJY VisualNext 3D Endoscopic Vision System, Substantially Equivalent on 2025-05-21. Applicant: Hjy Smart Medical Device Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hjy Smart Medical Device Co., Ltd.
- Product code
- Code GWG
- Device class
- Class 2
- Regulation
- 21 CFR 882.1480
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei, TW
Recent devices under product code GWG
view allMore clearances from Hjy Smart Medical Device Co., Ltd.
view allAdverse events under product code GWG
product code GWG- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.