HJY VisualNext Endoscopic Vision System— 510(k) K222735

Name: FDA 510(k) clearance K222735
Creator: U.S. Food and Drug Administration
Published: 2023-07-28

Substantially Equivalent

Hjy Smart Medical Device Co., Ltd.

FDA 510(k) clearance K222735 for HJY VisualNext Endoscopic Vision System, Substantially Equivalent on 2023-07-28. 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: 2022-09-09
Decision date: 2023-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWG

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K253602 — Precision S 4K Sinuscope2026-06-04
K253679 — Hydro Irrigation System2026-05-08
K243429 — HJY VisualNext 3D Endoscopic Vision System2025-05-21
K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)2025-04-09
K233391 — cCeLL - In vivo2024-08-21

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.