FDA 510(k)

HJY VisualNext 3D 内窥镜视觉系统

K号: K243429 · 2025-05-21

决定日期2025-05-21

产品代码GWG

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决定实质等同

器械摘要

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

常见问题

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. The listed applicant is Hjy Smart Medical Device Co., Ltd.. The 510(k) number is K243429.

When did HJY VisualNext 3D Endoscopic Vision System receive FDA 510(k) clearance?

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

Who is the listed applicant for HJY VisualNext 3D Endoscopic Vision System?

The FDA 510(k) record lists Hjy Smart Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

列明Hjy Smart Medical Device Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K222735HJY VisualNext 内窥镜视觉系统

官方来源

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