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

    POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM

    K Number: K070759 · Decision May 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    19
    Review Days
    62

    Basic Information

    Device Name
    POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
    K Number
    K070759
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VIDACARE CORPORATION
    Date Received
    March 20, 2007
    Decision Date
    May 21, 2007
    Product Code
    FCF
    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
    FCF Instrument, Biopsy, Mechanical, Gastrointestinal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FCF), ordered by most recent decision date.

    POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AMCATH DISPOSABLE BIOPSY FORCEPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OVAL CUP BIOPSY FORCEP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PHARMA-PLAST RECTAL TIP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by VIDACARE CORPORATION

    K Number Device Name
    K132583 EZ-IO INTRAOSSEOUS INFUSION SYSTEM
    K120661 THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
    K113872 THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
    K101026 POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO
    K091140 EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
    K081713 VERTEBRAL ACCESS SYSTEM BY VIDACARE
    K072045 ONCONTROL BONE MARROW BIOPSY SYSTEM
    K063567 EZ-MIO STERNAL
    K063142 MANUAL PD-IO; POWERED PD-IO
    K062956 EZ-MIO, EZ-IO DISTAL TIBIA
    Search all 19 clearances from VIDACARE CORPORATION →