Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HJY VisualNext 3D Endoscopic Vision System

K-Number: K243429 · 2025-05-21

ApplicantHjy Smart Medical Device Co., Ltd.
Decision Date2025-05-21
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HJY VisualNext 3D Endoscopic Vision System is a medical device manufactured by Hjy Smart Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2025-05-21 under approval number K243429. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HJY VisualNext 3D Endoscopic Vision System?

HJY VisualNext 3D Endoscopic Vision System is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Hjy Smart Medical Device Co., Ltd.. The 510(k) number is K243429.

When was HJY VisualNext 3D Endoscopic Vision System approved by the FDA?

HJY VisualNext 3D Endoscopic Vision System received FDA 510(k) clearance on 2025-05-21, under approval number K243429.

What company makes HJY VisualNext 3D Endoscopic Vision System?

HJY VisualNext 3D Endoscopic Vision System is manufactured by Hjy Smart Medical Device Co., Ltd..

What is the FDA product code for HJY VisualNext 3D Endoscopic Vision System?

The FDA product code for HJY VisualNext 3D Endoscopic Vision System is GWG.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED

Other Devices by Hjy Smart Medical Device Co., Ltd.

K222735HJY VisualNext Endoscopic Vision System

Related Devices (Code: GWG)

K161112KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. K152699Apollo SystemPenumbra, Inc. K170667QEVO System with KINEVO 900Carl Zeiss Meditec, AG K171332Artemis Neuro Evacuation DevicePenumbra, Inc. K170462KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc. K162880TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑