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

    IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT

    K Number: K092049 · Decision Oct 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    3
    Review Days
    94

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    Basic Information

    Device Name
    IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT
    K Number
    K092049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Sainath Intellectual Properties, LLC
    Date Received
    July 7, 2009
    Decision Date
    October 9, 2009
    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 Sainath Intellectual Properties, LLC

    K Number Device Name
    K102572 IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT
    K100173 IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT