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510(k) Data Aggregation

    K Number
    K160149
    Device Name
    Miret Grasper, Alligator, Miret Grasper, Maryland
    Date Cleared
    2016-08-30

    (222 days)

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

    MIRET SURGICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Miret Surgical Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold and manipulate soft tissues.
    Device Description
    Fabricated from a stainless steel alloy, Miret Surgical Instruments are single-use disposable devices designed for grasping, holding and manipulating tissue. They consist of an integrated needle/cannula shaft that attaches to a working instrument. The shaft can be introduced percutaneously to the surgical site, after which the working instrument can be operated. The working instrument is controlled through a handle and locking mechanism on the proximal end of the device. The Miret Surgical Instruments can be used in a variety of surgical applications, including laparoscopic surgery after insufflation, and are available in either a Maryland or Alligator grasper configuration.
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