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510(k) Data Aggregation

    K Number
    K162387
    Device Name
    U-IGNITE Bladeless Trocar
    Date Cleared
    2017-01-11

    (139 days)

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

    TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The U-IGNITE Bladeless Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments.
    Device Description
    It is a rigid hand-held surgical instrument with a rounded conical point used to manually puncture a bodily entry point to assist in the location and positioning of gently part the surrounding soft tissue. The trocar assembly punctures the muscle and tissue layers in the body. The trocar assembly's obturator is removed leaving the cannula to provide a port through which laparoscopes and other laparoscopic instruments can be introduced. The cannula sealing system shall be able to maintain pneumoperitoneum. The U-IGNITE Bladeless Trocar is a sterile single patient use instrument consisting of a radiolucent sleeve and obturator in various sizes diameter. The obturator contains a clear, taped optical element. The obturator accommodate an appropriate sized 0 degree endoscope and provide visibility of individual tissue layers during insertion. Basic type do not have the optical element for its obturator. In addition, the U-IGNITE Bladeless Trocar with Endo-assistant part is a design enhancement that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocarinduced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar. The trocar sleeves for the 12 mm devices contain two seals, an outer integrated removable self-adjusting seal that accommodates instruments ranging from 5mm to 12 mm in diameter where indicated and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted or withdraw through the trocar. The 5 mm trocar sleeve does not contain an integrated removable outer seal and accommodates only 5 mm instruments. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve. This is an irradiation sterilized single use disposable device to avoid cross infection.
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    K Number
    K162648
    Device Name
    U-Blade Veress Needle
    Date Cleared
    2016-12-12

    (81 days)

    Product Code
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The U-Blade Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
    Device Description
    The U-Blade Veress Needle is a slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a surgical/radiological procedural method. It is used for percutaneous insertion into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures. The device consists of an external stainless steel needle tube with a sharp point to puncture tissue. It is also equipped with an internal spring-loaded round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage to internal organs from the sharp point. The subject device also has a handle with a red indicator mark to verify when the spring-loaded obturator is retracted and a valve connector which connects to an insufflation pump. As described in the following table, the U-Blade Veress Needle is available in 120mm and 150mm needle lengths and two types of handles with different shapes (U shape and Bugle). | Model Number | Length (mm) | Comments | |--------------|-------------|--------------------| | UV120 | 120 mm | U shape handle | | UV150 | 150 mm | U shape handle | | BV120 | 120 mm | Bugle shape handle | | BV150 | 150 mm | Bugle shape handle | This is a sterile and single-use device.
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