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

    Star Tissue Marker

    K Number: K170905 · Decision Apr 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    Star Tissue Marker
    K Number
    K170905
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scion Medical Technologies, LLC
    Date Received
    March 28, 2017
    Decision Date
    April 27, 2017
    Product Code
    NEU
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NEU Marker, Radiographic, Implantable

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    Other Clearances by Scion Medical Technologies, LLC

    K Number Device Name
    K161234 CASSI II Rotational Core Biopsy System
    K153189 Beacon Tissue Marker (SE)
    K140835 GENERAL AND PLASTIC SURGERY
    K130763 BEACON TISSUE MARKER
    K123606 CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE