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

    GORE-TEX PERITONEAL CATHETERR

    K Number: K820909 · Decision May 21, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    47
    Applicant Total
    163
    Review Days
    50

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    Basic Information

    Device Name
    GORE-TEX PERITONEAL CATHETERR
    K Number
    K820909
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    April 1, 1982
    Decision Date
    May 21, 1982
    Product Code
    FJS
    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
    FJS Catheter, Peritoneal, Long-Term Indwelling

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

    K Number Device Name
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    K191773 GORE BIO-A Tissue Reinforcement
    K181940 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
    K173333 GORE ENFORM Biomaterial
    K163576 GORE SYNECOR Preperitoneal Biomaterial
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