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510(k) Data Aggregation

    K Number
    K152206
    Device Name
    SurgiPure XD Reconstructive Tissue Matrix
    Date Cleared
    2016-03-08

    (215 days)

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

    TISSUE REGENIX GROUP PLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SurgiPure® XD Reconstructive Tissue Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or buttressing material to obtain the desired surgical outcome. The device is intended for single use (single patient one-time use) only.
    Device Description
    SurgiPure™ XD Reconstructive Tissue Matrix is a surgical mesh made from porcine dermis which then undergoes a decellularisation process. The collagen matrix is subsequently packed into a double pouch and then sterillsed by irradiation. SurgiPure™ XD acts as a surgical mesh for soft tissue repair to provide a scaffold to the patient to allow cellular infiltration, neovascularisation and collagen deposition.
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