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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 the device name listed in this FDA 510(k) record. The listed applicant is Huger Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-07-01 under 510(k) 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. The listed applicant is Huger Medical Instrument Co., Ltd.. The 510(k) number is K241639.

When did Single-use Video Ureterorenoscope (SVU-220US) receive FDA 510(k) clearance?

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

Who is the listed applicant for Single-use Video Ureterorenoscope (SVU-220US)?

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

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.

Other records listing Huger Medical Instrument 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.

K230475Medical Video Endoscope System

Related Devices (Code: FGB)

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.

K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd.K260013CVAC Image ProcessorCalyxo, Inc.K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)Zhejiang Geyi Medical Instrument Co., Ltd.

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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