# Hjy Smart Medical Device Co., Ltd.

- Location (FDA's records): Taipei City, TW
- FDA decisions: 2 (2023–2025): 2 510(k) clearances
- Product codes: GWG (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)

## Its most-cited devices
- K222735: HJY VisualNext Endoscopic Vision System (2023), cited by 1

## Recent decisions
- K243429: HJY VisualNext 3D Endoscopic Vision System (May 21, 2025)
- K222735: HJY VisualNext Endoscopic Vision System (Jul 28, 2023)

Source page: https://510kreport.com/company/hjy-smart-medical-device