FDA 510(k)

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

N.º K: K240401 · 2024-07-26

SolicitanteOrigyn Medical Technology (Hangzhou) Co., Ltd.

Fecha de decisión2024-07-26

Código de productoHIH

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

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