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

    YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS

    K Number: K131500 · Decision Jan 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    35
    Applicant Total
    207
    Review Days
    245

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    Basic Information

    Device Name
    YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
    K Number
    K131500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap, Inc.
    Date Received
    May 24, 2013
    Decision Date
    January 24, 2014
    Product Code
    HCH
    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
    HCH Clip, Aneurysm

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