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

    LIFECELL TISSUE EXPANDER

    K Number: K112534 · Decision Aug 10, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    54
    Applicant Total
    10
    Review Days
    344

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    Basic Information

    Device Name
    LIFECELL TISSUE EXPANDER
    K Number
    K112534
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifecell Corp.
    Date Received
    September 1, 2011
    Decision Date
    August 10, 2012
    Product Code
    LCJ
    Advisory Committee
    Unknown
    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
    LCJ Tissue Expander And Accessories

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    Other Clearances by Lifecell Corp.

    K Number Device Name
    K130817 LTN - LAPAROSCOPIC SURGICAL MESH
    K121289 LTM-LABAROSCOPIC SURGICAL MESH
    K082176 LTM-BPS SURGICAL MESH
    K082103 LTM WOUND DRESSING
    K080353 LTM-T SURGICAL MESH
    K071986 LTM-RC SURGICAL MESH
    K070560 LRTM SURGICAL MESH
    K061208 LIFECELL DURAL SUBSTITUTE MATRIX
    K052735 ALLOCRAFT DBM