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

    CASSI II Rotational Core Biopsy System

    K Number: K161234 · Decision Aug 3, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    6
    Review Days
    93

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    Basic Information

    Device Name
    CASSI II Rotational Core Biopsy System
    K Number
    K161234
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scion Medical Technologies, LLC
    Date Received
    May 2, 2016
    Decision Date
    August 3, 2016
    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 Scion Medical Technologies, LLC

    K Number Device Name
    K170905 Star Tissue Marker
    K153189 Beacon Tissue Marker (SE)
    K140835 GENERAL AND PLASTIC SURGERY
    K130763 BEACON TISSUE MARKER
    K123606 CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE