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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 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 2023-07-28 under 510(k) 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. The listed applicant is Hjy Smart Medical Device Co., Ltd.. The 510(k) number is K222735.

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

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

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

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

Other records listing Hjy Smart Medical Device Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243429HJY VisualNext 3D Endoscopic Vision System

Related Devices (Code: GWG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253602Precision S 4K SinuscopeStryker EndoscopyK253679Hydro Irrigation SystemStryker InstrumentsK243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd.K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences CorporationK233391cCeLL - In vivoVPIX Medical, Inc.K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC

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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