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510(k) Data Aggregation

    K Number
    K172835
    Device Name
    GRI-Alleset Veress Needle
    Manufacturer
    GRI Medical and Electronic Technology Co., Ltd.
    Date Cleared
    2018-06-11

    (265 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    GRI Medical and Electronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GRI-Alleset Veress Needle is a disposable, single-use, sterile device intended to be used in minimally-invasive abdominal procedures for the establishment of pneumoperitoneum.
    Device Description
    The GRI-Alleset Veress Needle is a disposable, single-use, sterile surgical instrument used during minimally invasive surgery for the establishment of peritoneum of the abdominal cavity prior to abdominal surgery. The device is comprised of a 14 gauge stainless steel needle (120mm and 150mm in length) which is attached to a plastic handle that contains a stopcock with a luer lock connector. The spring-loaded, blunt stylet extends beyond the needle tip and retracts as the needle is pushed through the abdominal tissue; it automatically advances forward once the peritoneum is penetrated. A red safety indicator, attached to the proximal end of the stylet, is exposed above the handle as an indication of an exposed needle tip. The device is provided sterile via ethylene oxide.
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