BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

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

    K Number: K240401 · Decision Jul 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    1
    Review Days
    168

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    Basic Information

    Device Name
    ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
    K Number
    K240401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Origyn Medical Technology (Hangzhou) Co., Ltd.
    Date Received
    February 9, 2024
    Decision Date
    July 26, 2024
    Product Code
    HIH
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIH Hysteroscope (And Accessories)

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