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

    GENTLE COLONICS IRRIGATION SYSTEM

    K Number: K002102 · Decision Feb 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    574

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    Basic Information

    Device Name
    GENTLE COLONICS IRRIGATION SYSTEM
    K Number
    K002102
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5220
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gentle Colonics, Inc.
    Date Received
    July 12, 2000
    Decision Date
    February 6, 2002
    Product Code
    KPL
    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
    KPL Colonic Irrigation System

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    Other Clearances by Gentle Colonics, Inc.

    K Number Device Name
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