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510(k) Data Aggregation

    K Number
    K130547
    Device Name
    ENDOFORM RECONSTRUCTIVE TEMPLATE
    Manufacturer
    MESYNTHE LTD
    Date Cleared
    2013-05-31

    (88 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MESYNTHE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoform™ Reconstructive Template is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include, but are not limited to the following procedures; hernioplasty and repair of body wall defects. The device allows reinforcement or bridging of a deficit to obtain the desired surgical outcome. Endoform™ Reconstructive Template is intended for single use only.
    Device Description
    The Mesynthes Endoform™ Reconstructive Template (ERT) is a surgical mesh comprising either a single layer of decellularized extracellular matrix (ECM) or alternatively, multiple layers (2- to 10- layers) of ECM bonded together by dehydrothermal lamination and polyglycolic acid (PGA) suture material.
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