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510(k) Data Aggregation

    K Number
    K150549
    Device Name
    Reactor(TM) Trocar and Sleeve
    Date Cleared
    2015-06-01

    (90 days)

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

    Sharp Medical Prducts, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sharp Medical Reactor™ Trocar and Sleeve has indications in the creation of a port of entry into the thoracic cavity and allows the user to create and maintain limited access into the intention of chest tube placement.
    Device Description
    The Reactor™ Trocar consists of an obturator with a flat tip at the distal end which encloses a circular scalpel shaped knife blade. The blade extends approximately 1mm and immediately retracts when the trigger is squeezed. The clear sleeve with printing accommodates instruments up to 36 Fr. or 12 mm.
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