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510(k) Data Aggregation

    K Number
    K063462
    Device Name
    NEATSTITCH NEATCLOSE SUTURING DEVICE
    Manufacturer
    Date Cleared
    2007-01-12

    (58 days)

    Product Code
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEAT STITCH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeatClose Suturing Device is intended for the approximation and/or ligation of soft tissues in laparoscopic procedures.
    Device Description
    The NeatClose Suturing Device has three major component: 1) a reusable Handle, 2) a single-use disposable cartridge (containing a natented needle guides and needles), and 3) a suture. The cartridge (including the pre-loded suture) is assembled onto the Handle. The device is then inserted through the access site through the port working channel (or without it), the needle guides are deployed and the device is withdrawn till the needle guides contact the inner abdominal wall. Then the needles are deployed, penetrating the tissue and retrieved in the cartridge. Right after, automatically, the needle guides are retracted to the cartridge as well. Then the device is completely withdraws, leaving the suture to be tied by the surgeon as he/she routinely with
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