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    K Number
    K131563
    Device Name
    SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM
    Manufacturer
    OPUS KSD, INC.
    Date Cleared
    2014-04-09

    (314 days)

    Product Code
    GDWGAGQQS
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPUS KSD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SubQ It!™ Bioabsorbable Skin Closure System is intended for use in humans for abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.
    Device Description
    The SubQ It!" Bioabsorbable Skin Closure System comprises bioabsorbable fasteners made of 82/18 L-lactide/Glycolide copolymer, a well-established material for resorbable medical devices. The fasteners have two legs with barbed tips (4.3mm long, 0.88mm diameter and spaced 2.75mm center-to-center). The fasteners are inserted using the SubQ It!" Stapler.
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