510(k) Report

FDA applicant

Hjy Smart Medical Device Co., Ltd.

Taipei City, TW2 decisions2023–20250 recalls

FDA records 2 decisions for Hjy Smart Medical Device Co., Ltd. (Taipei City, TW) from 2023 to 2025: 2 510(k) clearances. All are in product code GWG (Endoscope, Neurological). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Hjy Smart Medical Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 12025: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Hjy Smart Medical Device Co., Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GWGEndoscope, Neurological2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222735HJY VisualNext Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd. · 2025
  • K222735HJY VisualNext Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd. · 2023

All 2 as Hjy Smart Medical Device Co., Ltd. →