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FDA 510(k)

HJY VisualNext Endoscopic Vision System

K-Number: K222735 · 2023-07-28

ApplicantHjy Smart Medical Device Co., Ltd.
Decision Date2023-07-28
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HJY VisualNext Endoscopic Vision System is a medical device manufactured by Hjy Smart Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-07-28 under approval number K222735. 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 Endoscopic Vision System?

HJY VisualNext Endoscopic Vision System is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Hjy Smart Medical Device Co., Ltd.. The 510(k) number is K222735.

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

HJY VisualNext Endoscopic Vision System received FDA 510(k) clearance on 2023-07-28, under approval number K222735.

What company makes HJY VisualNext Endoscopic Vision System?

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

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

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

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

K243429HJY VisualNext 3D 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

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

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