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

    INDWELLING FECAL MANAGEMENT SYSTEM

    K Number: K012113 · Decision May 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    243
    Same Product Code
    648
    Applicant Total
    2
    Review Days
    301

    Basic Information

    Device Name
    INDWELLING FECAL MANAGEMENT SYSTEM
    K Number
    K012113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BOWEL MANAGEMENT SYSTEMS, LLC
    Date Received
    July 6, 2001
    Decision Date
    May 3, 2002
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by BOWEL MANAGEMENT SYSTEMS, LLC

    K Number Device Name
    K023344 INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE