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

    SILICONE ELASTOMER COATED LATEX FOLEY

    K Number: K810630 · Decision Mar 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    236
    Applicant Total
    56
    Review Days
    22

    Basic Information

    Device Name
    SILICONE ELASTOMER COATED LATEX FOLEY
    K Number
    K810630
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    G.D. SEARLE AND CO.
    Date Received
    March 9, 1981
    Decision Date
    March 31, 1981
    Product Code
    KOD
    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
    KOD Catheter, Urological

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