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510(k) Data Aggregation

    K Number
    K150906
    Device Name
    ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
    Manufacturer
    EHICON INC.
    Date Cleared
    2015-07-24

    (112 days)

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

    EHICON INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ULTRAPRO ADVANCED™ Mesh may be used for the repair of abdominal fascial deficiencies, such as hernias, that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
    Device Description
    ULTRAPRO ADVANCED™ Macroporous Partially Absorbable Mesh is a sterile, partially absorbable mesh device designed for the repair of hernias and other fascial defects. The implant device is composed of a macroporous mesh, manufactured out of dyed (phtalocyanine blue) and undyed non absorbable polypropylene monofilaments (3.5 mil PROLENE™) as well as a twist yarn, composed of dyed (phtalocyanine blue) and undyed non absorbable polypropylene monofilaments (3.5 mil PROLENE™) and undyed absorbable poliglecaprone 25 monofilaments (5 mil MONOCRYL™). The mesh provides blue stripes for orientation.
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