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510(k) Data Aggregation

    K Number
    K090432
    Device Name
    HEMORPEX SYSTEM
    Date Cleared
    2009-05-29

    (99 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANGIOLOGICA B. M. SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HEMORPEX SYSTEM (HPS) is intended for physician use to examine the anal sphincter and anus and to perform several diagnostic and therapeutic procedures, such as surgical treatment for hemorrhoidal disease.
    Device Description
    HEMORPEX SYSTEM (HPS) is a diagnostic and operating anoscope, which is mainly intended for the surgical treatment of the hemorrhodal disease through dearterializing hemorrhoidopexy. HemorPex System (HPS) is a device made by a fixed part which remains in contact with the anoderma and the sensible mucosa of the anal canal, and by a rotating operative part which includes the window through which the suture stitches are posed. The instrument has 6 preset positions of the operative window. In these positions there are the 6 terminal branches of the superior hemorrhoidal artery.
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    K Number
    K043191
    Device Name
    REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
    Date Cleared
    2005-05-16

    (180 days)

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

    ANGIOLOGICA B. M. SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Angimesh Pre: "Repair of inguinal hernia defects." Folded Mesh: "Repair of inguinal hernia defects." Repol Plug Basic: "Repair of inguinal hernia defects." Repol Plug Cap: "Repair of inguinal hernia defects." Repol Plug Flower: "Repair of inguinal hernia defects." Repol Angimesh: "To reinforce soft tissue where weakness exists, i.e., repair of hernias." Wings Mesh: "Use in all kind of hernia repair requiring reinforcement with nonabsorbable support material."
    Device Description
    Monofilament polypropylene mesh, available in various weights, rigidity, shapes and sizes, to allow an easy use in surgical techniques.
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