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510(k) Data Aggregation

    K Number
    K153632
    Device Name
    Endoform Reconstructive Template
    Manufacturer
    Aroa Biosurgery Limited (Formerly Mesynthes Limited)
    Date Cleared
    2016-06-16

    (181 days)

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

    Aroa Biosurgery Limited (Formerly Mesynthes Limited)

    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 the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
    Device Description
    Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for soft tissue reconstruction. The device design includes thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of Endoform™ Reconstructive Template - Non-Absorbable devices includes lyophilization of single sheets of OFM followed by embroidery with polypropylene. Devices are terminally sterilized by ethylene oxide (EO) sterilization.
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    K Number
    K153633
    Device Name
    Endoform Reconstructive Template
    Manufacturer
    Aroa Biosurgery Limited (Formerly Mesynthes Limited)
    Date Cleared
    2016-03-15

    (88 days)

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

    Aroa Biosurgery Limited (Formerly Mesynthes Limited)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoform Reconstructive Template is intended for usc as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
    Device Description
    The Aroa Endoform Reconstructive Template ("ERT") is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for implant applications as part of soft tissue reconstruction. The device design includes a range of thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of ERT devices includes lyophilization of single sheets of OFM followed by embroidery with polyglycolic acid (PGA). Devices are terminally sterilized by ethylene oxide (EO) sterilization. The device has received FDA clearance (K130547) for sizes up to 200cm2.
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