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510(k) Data Aggregation

    K Number
    K955412
    Device Name
    A.S.D. SAFETY TROCAR
    Date Cleared
    1996-05-14

    (169 days)

    Product Code
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN SURGICAL DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The A.S.D. Surgical Trocar is intended for use during vascular and gynecological laparoscopy and other abdominal procedures, to create an entry point for laporascopic instruments into the abdominal cavity. Surgical instruments of the appropriate size can be safely quided and entered into the abdominal cavity through the cannula.
    Device Description
    The A.S.D. Surgical Trocar is a single-use, sterile, temporary, disposable device intended for use during laparoscopy, to create an entry point for laporascopic into the abdominal cavity. Surgical instruments of the appropriate size can be safely guided and entered into the abdominal cavity through the cannula. The Trocar consists of: 1) an obturator with a pointed pyramidal tip, 2) a spring-baded safety shield to of the obturator after lissue penetration. 3) a radiolucent cannula (sleeve) with a gasket system to prevent leakage of gas during i setion and withdrawal of instruments 4) an accessory stability thread to help secure the cannula in the body during use. An collional accessory, an obturator adapter is available to be used as a reducer with the 1011mm system. When the adapter is used, 5 mm instruments are accepted into the 10/11mm trocar. The A.S.D. Trocar is available in the 10/11mm and 5mm sizes. The size of the size of the size of the instrument that can be entered in the trocar. The sleeve lengths available for the 1011mm and 150mm; and for the 5mm trocar are 70 mm and 100mm. The stability threads are available in 38 mm and 51 mm lengths. The A.S.D. Trocar is made of aluminum, stainless steel, polycarbonate and silicone rubber.
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