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

    WATERS ILEAL RESERVOIR CATHETER

    K Number: K813494 · Decision Dec 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    0
    Applicant Total
    12
    Review Days
    17

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    Basic Information

    Device Name
    WATERS ILEAL RESERVOIR CATHETER
    K Number
    K813494
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5030
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Waters Instruments, Inc.
    Date Received
    December 14, 1981
    Decision Date
    December 31, 1981
    Product Code
    KPH
    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
    KPH Catheter, Rectal For Continent Ileostomy

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