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

    GORE-TEX CATHETER

    K Number: K840864 · Decision Jun 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    163
    Review Days
    95

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    Basic Information

    Device Name
    GORE-TEX CATHETER
    K Number
    K840864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    February 27, 1984
    Decision Date
    June 1, 1984
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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

    K Number Device Name
    K250410 GORE® Tri-Lobe Balloon Catheter
    K240083 GORE® PROPATEN® Vascular Graft
    K232312 GORE® PROPATEN® Vascular Graft
    K233551 GORE® ACUSEAL Vascular Graft
    K231505 GORE® ACUSEAL Vascular Graft
    K191773 GORE BIO-A Tissue Reinforcement
    K181940 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
    K173333 GORE ENFORM Biomaterial
    K163576 GORE SYNECOR Preperitoneal Biomaterial
    K170740 GORE VIABIL Short Wire Biliary Endoprosthesis
    Search all 163 clearances from W. L. Gore & Associates, Inc. →