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

    CONE CATH

    K Number: K931156 · Decision Jul 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    12
    Review Days
    114

    Basic Information

    Device Name
    CONE CATH
    K Number
    K931156
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SIERRA LABORATORIES, INC.
    Date Received
    March 9, 1993
    Decision Date
    July 1, 1993
    Product Code
    EXJ
    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
    EXJ Device, Incontinence, Urosheath Type, Sterile

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