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

    TUBING, AXIOM SILICONE PENROSE

    K Number: K781749 · Decision Dec 4, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    22
    Applicant Total
    28
    Review Days
    48

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    Basic Information

    Device Name
    TUBING, AXIOM SILICONE PENROSE
    K Number
    K781749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Axiom Medical, Inc.
    Date Received
    October 17, 1978
    Decision Date
    December 4, 1978
    Product Code
    KDH
    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
    KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

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