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

    SMARTWAND-DTX

    K Number: K093557 · Decision Dec 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    32

    Basic Information

    Device Name
    SMARTWAND-DTX
    K Number
    K093557
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CLEARCOUNT MEDICAL SOLUTIONS
    Date Received
    November 16, 2009
    Decision Date
    December 18, 2009
    Product Code
    LWH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    Y

    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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