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FDA 510(k)

Single-use Video Ureterorenoscope (SVU-220US)

K-Number: K241639 · 2024-07-01

ApplicantHuger Medical Instrument Co., Ltd.
Decision Date2024-07-01
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single-use Video Ureterorenoscope (SVU-220US) is a medical device manufactured by Huger Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-07-01 under approval number K241639. 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 Single-use Video Ureterorenoscope (SVU-220US)?

Single-use Video Ureterorenoscope (SVU-220US) is a medical device that received FDA 510(k) clearance on 2024-07-01. It is manufactured by Huger Medical Instrument Co., Ltd.. The 510(k) number is K241639.

When was Single-use Video Ureterorenoscope (SVU-220US) approved by the FDA?

Single-use Video Ureterorenoscope (SVU-220US) received FDA 510(k) clearance on 2024-07-01, under approval number K241639.

What company makes Single-use Video Ureterorenoscope (SVU-220US)?

Single-use Video Ureterorenoscope (SVU-220US) is manufactured by Huger Medical Instrument Co., Ltd..

What is the FDA product code for Single-use Video Ureterorenoscope (SVU-220US)?

The FDA product code for Single-use Video Ureterorenoscope (SVU-220US) is FGB.

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Other Devices by Huger Medical Instrument Co., Ltd.

K230475Medical Video Endoscope System

Related Devices (Code: FGB)

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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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