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510(k) Data Aggregation

    K Number
    K232062
    Device Name
    Uni-port
    Manufacturer
    Dalim Medical Corp.
    Date Cleared
    2024-01-16

    (189 days)

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

    Dalim Medical Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uni-port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
    Device Description
    Uni-port is a single use manual operated surgical retractor comprised of three components; main body, wound retractor and filter. The main body consist of combinations of several ports of various size (5mm, 12mm, 15mm and 28mm). The wound retractor is a flexible polyurethane film that has two rings attached at each end and a Thandle connected with thread for easily removal after procedure. The single (lower) ring is inserted into the abdomen for fixation and double (upper) ring is connected with main body. The filter is provided separately to filter out harmful gas generated in the abdominal cavity, it is easy to ensure a clear view.
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