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

    Aesculap Slim Clip Applier

    K Number: K180914 · Decision Apr 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    13
    Applicant Total
    207
    Review Days
    8

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    Basic Information

    Device Name
    Aesculap Slim Clip Applier
    K Number
    K180914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4175
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap, Inc.
    Date Received
    April 9, 2018
    Decision Date
    April 17, 2018
    Product Code
    HCI
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCI Applier, Aneurysm Clip

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