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510(k) Data Aggregation

    K Number
    K072814
    Device Name
    CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
    Manufacturer
    COVIDIEN
    Date Cleared
    2008-04-16

    (198 days)

    Product Code
    KDD, GEI
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KDD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures.
    Device Description
    Convenience kit of laparoscopic instruments. The convenience kit contains various configurations of tools for the performance of laparoscopic procedures. These tools provide laparoscopic access, tissue dissection and manipulation, hemostasis, and specimen collection.
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    K Number
    K011514
    Device Name
    INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
    Manufacturer
    KENCAP LTD.
    Date Cleared
    2001-08-13

    (88 days)

    Product Code
    KDD
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KDD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K971317
    Device Name
    NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
    Manufacturer
    NATIONAL HEALTHCARE MFG. CORP.
    Date Cleared
    1997-05-08

    (29 days)

    Product Code
    KDD
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KDD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Orthopedic Kit or Tray
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    K Number
    K960456
    Device Name
    DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
    Manufacturer
    DENVER BIOMATERIALS, INC.
    Date Cleared
    1996-04-01

    (62 days)

    Product Code
    KDD
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    KDD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Denver® Paracentesis Needle, Paracentesis Needle with Drainage Binc, and the Denver Traracentesis Tray are indicated for use in removing from cac personed to be used for both diagnostic and therapeutic abdominal paracentesis procedures.
    Device Description
    The Denver® Paracentesis Needle is a sterile device, for single use only. It is not to be resterilized. Components in the fluid path are non pyrogenic. This device consists of an inner two-part trocar, an outer drainage cannula, and a trocar/cannula housing. The inner two-part trocar is a rounded, closed end tube with side holes, coaxially housed within a sharp-beveled hollow needle and the outer drainage cannula. The outer drainage cannula has a beveled tip and distal side holes to facilitate drainage. As the two-part trocar penetrates the abdominal wall, the blunt portion of the trocar is forced back within the shaft of the needle portion of the trocar, exposing the sharp-beveled needle. The trocar/cannula housing contains a red indicator which is visible when the sharp-beveled needle is exposed. When the needle encounters low resistance, such as when the abdominal cavity is entered, the blunt portion of the trocar automatically re-extends out beyond the sharp needle, thereby helping protect against inadvertent organ puncture. Once the blunt portion of the trocar re-extends beyond the needle, the red indicator is no longer visible. Proper position in an area of fluid may also be confirmed by attaching a syringe to the end of the device and attempting aspiration. Once in the abdominal cavity, the two-part trocar is removed, leaving the outer drainage cannula and housing in place for the paracentesis procedure. The Denver® Paracentesis Needle with Drainage Line is a sterile device intended for single use only. It is not to be resterilized. The product contains one Denver® Paracentesis Needle, one drainage tubing line, and connectors to allow attachment to wall suction or a vacuum bottle. The Denver® Paracentesis Tray is a sterile device intended for single use only. It is not to be resterilized. The tray contains one Denver® Paracentesis Needle, one drainage tubing line, connectors to allow attachment to wall suction or a vacuum bottle, and the primary components needed for performing the paracentesis procedure.
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