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

    ASLAN KNOT PUSHER

    K Number: K950924 · Decision Mar 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    13

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    Basic Information

    Device Name
    ASLAN KNOT PUSHER
    K Number
    K950924
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aslan Medical Technologies, Ltd.
    Date Received
    March 1, 1995
    Decision Date
    March 14, 1995
    Product Code
    FDE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FDE Laparoscopy Kit

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