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

    Single Use Surgical Suction Irrigator

    K Number: K161421 · Decision Jun 24, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    32

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    Basic Information

    Device Name
    Single Use Surgical Suction Irrigator
    K Number
    K161421
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jiangsu Haize Medical Scientific Development Co., Ltd.
    Date Received
    May 23, 2016
    Decision Date
    June 24, 2016
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Jiangsu Haize Medical Scientific Development Co., Ltd.

    K Number Device Name
    K230593 Victan