FDA 510(k)

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)

Número K: K240401 · 2024-07-26

RequerenteOrigyn Medical Technology (Hangzhou) Co., Ltd.

Data da decisão2024-07-26

Código do produtoHIH

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) is the device name listed in this FDA 510(k) record. The listed applicant is Origyn Medical Technology (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K240401. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)?

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Origyn Medical Technology (Hangzhou) Co., Ltd.. The 510(k) number is K240401.

When did ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) receive FDA 510(k) clearance?

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) received FDA 510(k) clearance on 2024-07-26, under 510(k) number K240401.

Who is the listed applicant for ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)?

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

What is the FDA product code for ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)?

The FDA product code for ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) is HIH.

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