BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PIXEL APP

    K Number: K120473 · Decision Apr 9, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    53

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    Basic Information

    Device Name
    PIXEL APP
    K Number
    K120473
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gauss Surgical, Inc.,
    Date Received
    February 16, 2012
    Decision Date
    April 9, 2012
    Product Code
    LWH
    Advisory Committee
    General Hospital
    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
    LWH Counter, Sponge, Surgical

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