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

    SUNDT SLIM-LINE ANEURYSM CLIP APPLIER

    K Number: K982379 · Decision Dec 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    13
    Applicant Total
    206
    Review Days
    163

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    Basic Information

    Device Name
    SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
    K Number
    K982379
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4175
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    July 8, 1998
    Decision Date
    December 18, 1998
    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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