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FDA 510(k)

Medical Video Endoscope System

K-Number: K230475 · 2023-11-03

ApplicantHuger Medical Instrument Co., Ltd.
Decision Date2023-11-03
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medical Video Endoscope System is a medical device manufactured by Huger Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-11-03 under approval number K230475. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Video Endoscope System?

Medical Video Endoscope System is a medical device that received FDA 510(k) clearance on 2023-11-03. It is manufactured by Huger Medical Instrument Co., Ltd.. The 510(k) number is K230475.

When was Medical Video Endoscope System approved by the FDA?

Medical Video Endoscope System received FDA 510(k) clearance on 2023-11-03, under approval number K230475.

What company makes Medical Video Endoscope System?

Medical Video Endoscope System is manufactured by Huger Medical Instrument Co., Ltd..

What is the FDA product code for Medical Video Endoscope System?

The FDA product code for Medical Video Endoscope System is FGB.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Huger Medical Instrument Co., Ltd.

K241639Single-use Video Ureterorenoscope (SVU-220US)

Related Devices (Code: FGB)

K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K181977WiScope Digital Endoscope SystemOTU Medical, Inc. K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp. K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.

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.

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