Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K020614
    Device Name
    IRRIGATING CANNULA
    Manufacturer
    Date Cleared
    2002-05-24

    (88 days)

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

    CA GUARD, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CA-Guard Irrigating Cannula is intended to provide an access port to body cavities for endoscopes and endoscopic accessories when intraoperative irrigation or infusion of trocar wound surfaces is desired. The cannula has been tested for compatibility with lidocaine and marcane. Saline and water may also be used as irrigants. The CA-Guard Irrigating Cannula is inherently a needleless system and therefore, minimizes the possibility of "needle sticks" for healthcare workers, in accordance with the Needlestick Safety and Prevention Act of 2000.
    Device Description
    The Irrigating Cannula is a non-toxic, sterile, single use, disposable surgical access port. The device is intended to be inserted percutaneously into the peritoneal cavity to provide access for endoscopic instruments. The cannula is intended to replace the cannula that is supplied with the United States Surgical Versaport® 11mm Trocar System. The proximal end of the cannula is equipped with a female luer connector. The luer communicates with 6 longitudinal grooves on the surface of the inner member of the cannula. The inner member is covered with polyolefin shrink tubing. An array of twenty-four (24) holes deliver infusate to the compromised tissue surfaces of the trocar wound.
    Ask a Question

    Ask a specific question about this device

    K Number
    K992182
    Device Name
    CA GUARD, LTD. PSP (PORT SITE PROTECTOR)
    Manufacturer
    Date Cleared
    2000-07-18

    (386 days)

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

    CA GUARD, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Port-site Protector may be utilized in conjunction with devices intended for general laparoscopic cannula/trocar procedures.
    Device Description
    The device contains an elastomeric mechanism, which tethers the device to the inside of the abdominal wall. This mechanism affords the device a known insertion depth as well as a conductive path to the abdominal wall.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1