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510(k) Data Aggregation

    K Number
    K150705
    Device Name
    FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator
    Date Cleared
    2015-04-13

    (26 days)

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

    Minimally Invasive Devices, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The reusable FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator is an access device indicated for use with a disposable 8.5 - 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.
    Device Description
    The FloShield 10mm Endoscopic Conical Blunt Obturator is a re-usable stainless steel endoscopic instrument delivered non-sterile with the FloShield 10mm Endoscopic Cannula to the hospital where it is cleaned, sterilized (steam / moist heat), and assembled prior to surgery. The FloShield 10mm stainless steel Cannula mates with a disposable Applied Medical 8.5 -13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The stainless steel Cannula has the ability to connect to a standard male luer fitting, via the female luer that is present on the Cannula. The device will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter). The stainless steel Obturator has a conical blunt style tip which facilitates the insertion of the cannula through an incision site.
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