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510(k) Data Aggregation

    K Number
    K233263
    Device Name
    Disposable Trocars
    Manufacturer
    Hangzhou Kangji Medical Instrument Co., Ltd.
    Date Cleared
    2024-04-09

    (193 days)

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

    Hangzhou Kangji Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope.
    Device Description
    The Disposable Trocars includes Normal trocars (model A), Balloon trocars (model B), Thread trocars (model C) and Single-port trocars (model E). They are generally composed of cannula and obturator, with or without filter/cleaning ring/protector. The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope. If needed, the CO2 can be infused through the valve. The product is sterilized by Ethylene oxide and is a single-use product.
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    K Number
    K232401
    Device Name
    Disposable Veress Needles
    Manufacturer
    Hangzhou Kangji Medical Instrument Co., Ltd.
    Date Cleared
    2023-12-14

    (126 days)

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

    Hangzhou Kangji Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Veress Needles are 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 opic procedures.
    Device Description
    The Disposable Veress Needles are composed of needle, inner core, handle and made of medical grade stainless steel, PC, PE, ABS, and Model II has a silicone sleeve on the handle. The device is packed in Tyvek dialysis bag with 4058B Tyvek dialysis paper and ESE film. The contact duration is less than 24 hours. The device 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. The device is sterilized by EO and is intended for single-use only. The proposed device is available in a variety of needle lengths. There are two models for Disposable Veress needles: I, II. The difference between the two models is that the model II has a blue silicone sleeve outside the handle.
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