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

    LTM-LABAROSCOPIC SURGICAL MESH

    K Number: K121289 · Decision Aug 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    1
    Applicant Total
    10
    Review Days
    95

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LTM-LABAROSCOPIC SURGICAL MESH
    K Number
    K121289
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifecell Corp.
    Date Received
    April 30, 2012
    Decision Date
    August 3, 2012
    Product Code
    OXK
    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
    OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OXK), ordered by most recent decision date.

    LTN - LAPAROSCOPIC SURGICAL MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Lifecell Corp.

    K Number Device Name
    K130817 LTN - LAPAROSCOPIC SURGICAL MESH
    K112534 LIFECELL TISSUE EXPANDER
    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