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510(k) Data Aggregation

    K Number
    K082291
    Device Name
    A-LAP SET (A-LAP, EZAXESS, TROCAR)
    Manufacturer
    EZSURGICAL
    Date Cleared
    2009-01-02

    (144 days)

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

    EZSURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-Lap™ set has application for use in the creation and maintenance of an operative cavity such as the gynecologic, general, urologic and thoracic procedures. The set may be used in procedures to create and maintain a port of entry and for temporary retracting of tissue. The A-Lap™ retractor has application for use in the creation and maintenance of an operative cavity such as the gynecologic. general, urologic and thoracic procedures. The device may be used in procedures requiring temporary retracting of tissue. The EZaxess is intended for use in creating and for maintaining a port of entry in gynecologic, general, urologic and thoracic procedures.
    Device Description
    The A Lap™ set is laparoscopic surgical device compose of two components: A-Lap™ Retractor - a surgical retraction instrument used to move, retain or hold back internal organs in the operative region during laparoscopic surgery. The device purposes is to widen the access area to the treatment site (the surgical field), to grasp and retract the surrounding tissues, to maintain the resultant size of the access area and to secure the retracted tissue or organs by holding it away from the surgical site. The retraction is achieved by a 12 cm X 12 cm polyester mesh connected to stainless steel wires. EZaxess - a laparoscopic port included a 170 mm long and 10mm in diameter bladeless trocar and flexible cannula (10cm long and 10mm in diameter). The device is used to create and maintain a port of entry during laparoscopic surgery. The A Lap™ set is intended to be use for various laparoscopic surgical procedures, such as gynecologic, general, urologic and thoracic procedures. It is fully disposable and is intended for single use only.
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    K Number
    K071775
    Device Name
    DASH
    Manufacturer
    EZSURGICAL
    Date Cleared
    2007-08-07

    (39 days)

    Product Code
    GAD
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    EZSURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DASH™ is a deformable shape memory padded retractor, which is intended to retain or hold back organs and tissue in the course of surgical procedure. At the same time it serves as means of cushioning and absorption to the surgical area.
    Device Description
    The DASH™ is a deformable shape memory padded retractor
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