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

    GUARDPORT

    K Number: K921478 · Decision Jan 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    4
    Review Days
    1017

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    Basic Information

    Device Name
    GUARDPORT
    K Number
    K921478
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Health Improvement Assoc.
    Date Received
    March 30, 1992
    Decision Date
    January 11, 1995
    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 Health Improvement Assoc.

    K Number Device Name
    K905677 JEJUNO-CATH KIT
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    K770086 SANAR