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510(k) Data Aggregation

    K Number
    K153202
    Device Name
    iMESH Tacker
    Manufacturer
    Date Cleared
    2016-03-24

    (141 days)

    Product Code
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    THD LAP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
    Device Description
    Like the original iMESH Tacker, the modified iMESH Tacker is a sterile, single use device for the fixation of prosthetic material, such as a hernia mesh, onto soft tissue. The applicator features an articulating tip. The absorbable tack is made of synthetic polyester derived from a lactic acid and glycolic acid copolymer (PLA/PGA). The modified device's implantable Tack is violet colored. The Applicator is pre-loaded with up to 30 Tacks. The iMESH Tacker is comprised of 3 parts: - An in-line handle, - A shaft with an articulating tip - The bio-absorbable Tacks The modified iMESH Tacker is identical to the original iMESH Tacker with the exception of a change in the color of the tacks to violet, several minor internal changes and slight changes to packaging and certain components.
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