BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GENICON SUCTION IRRIGATION SYSTEM

    K Number: K041967 · Decision Nov 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    114

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    Basic Information

    Device Name
    GENICON SUCTION IRRIGATION SYSTEM
    K Number
    K041967
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genicon
    Date Received
    July 21, 2004
    Decision Date
    November 12, 2004
    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 Genicon

    K Number Device Name
    K132375 GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG
    K100090 IMPLANTABLE CLIP
    K061417 GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910
    K041968 GENICON BIPOLAR FORCEPS MODEL # 600-005-005