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

    RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537

    K Number: K071048 · Decision May 15, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    8
    Review Days
    32

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    Basic Information

    Device Name
    RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537
    K Number
    K071048
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rubicor Medical, Inc.
    Date Received
    April 13, 2007
    Decision Date
    May 15, 2007
    Product Code
    KNW
    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
    KNW Instrument, Biopsy

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    Other Clearances by Rubicor Medical, Inc.

    K Number Device Name
    K070275 FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE
    K053151 RUBICOR MAGIC BREAST BIOPSY DEVICE
    K052506 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108
    K032584 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629
    K030049 MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
    K023601 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
    K020047 RUBICOR BREAST BIOPSY DEVICE