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

    RB12 SUCTION RECTAL BIOPSY SYSTEM

    K Number: K062159 · Decision Sep 5, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    39

    Basic Information

    Device Name
    RB12 SUCTION RECTAL BIOPSY SYSTEM
    K Number
    K062159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AUS SYSTEMS PTY LTD.
    Date Received
    July 28, 2006
    Decision Date
    September 5, 2006
    Product Code
    FCK
    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
    FCK Instrument, Biopsy, Suction

    Similar 510(k) Clearances

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

    Howell Biliary Aspiration Needle

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

    MULTIPLE BIOPSY SYSTEM

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

    DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087

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

    DSNARE, MODEL 00711087

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

    MEHTA BRONCHIAL BIOSPY DRILL

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

    BIOPSY DEVICE ACCESSORY

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