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FDA 510(k)

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)

K-Number: K252929 · 2026-04-09

ApplicantAnhui Happiness Workshop Instruments Co., Ltd.
Decision Date2026-04-09
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Happiness Workshop Instruments Co., Ltd.. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K252929. 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 Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)?

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is Anhui Happiness Workshop Instruments Co., Ltd.. The 510(k) number is K252929.

When did Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) receive FDA 510(k) clearance?

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) received FDA 510(k) clearance on 2026-04-09, under 510(k) number K252929.

Who is the listed applicant for Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)?

The FDA 510(k) record lists Anhui Happiness Workshop Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)?

The FDA product code for Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) is FGB.

Related Clinical Trials

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.

NCT07630155Office-Based Ureteroscopy Utilizing a Single Use Digital, Flexible Ureteroscope for Upper Tract Urothelial CarcinomaRECRUITINGNCT05275192Utilization of a Videoscope in Periodontal RegenerationACTIVE_NOT_RECRUITING

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.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.K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine Medical Instrument Co., Ltd.

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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