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

    Hysteroscopy System

    K Number: K172151 · Decision Apr 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    Hysteroscopy System
    K Number
    K172151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5070
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chongquin Jinshan Science & Technology (Group) Co., Ltd.
    Date Received
    July 17, 2017
    Decision Date
    April 9, 2018
    Product Code
    HGH
    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
    HGH Cannula, Suction, Uterine

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