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FDA 510(k)

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

Número K: K252929 · 2026-04-09

RequerenteAnhui Happiness Workshop Instruments Co., Ltd.
Data da decisão2026-04-09
Código do produtoFGB
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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