BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GORE-TEX TUNNELER

    K Number: K844584 · Decision Jan 24, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    313
    Registration Numbers
    313
    Same Product Code
    70
    Applicant Total
    163
    Review Days
    62

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    Basic Information

    Device Name
    GORE-TEX TUNNELER
    K Number
    K844584
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4500
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    November 23, 1984
    Decision Date
    January 24, 1985
    Product Code
    DWS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWS Instruments, Surgical, Cardiovascular

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    Other Clearances by W. L. Gore & Associates, Inc.

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    K191773 GORE BIO-A Tissue Reinforcement
    K181940 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
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    K163576 GORE SYNECOR Preperitoneal Biomaterial
    K170740 GORE VIABIL Short Wire Biliary Endoprosthesis
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