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

    BIOPSY HANDY, MRI BIOPSY HANDY

    K Number: K102771 · Decision Jun 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    7
    Review Days
    273

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    Basic Information

    Device Name
    BIOPSY HANDY, MRI BIOPSY HANDY
    K Number
    K102771
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Somatex Medical Technologies GmbH
    Date Received
    September 24, 2010
    Decision Date
    June 24, 2011
    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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    K111692 TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
    K093064 TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
    K073095 TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560