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510(k) Data Aggregation

    K Number
    K172846
    Device Name
    Uterine Manipulator
    Manufacturer
    Beijing HangTian KaDi Technology R&D Institute
    Date Cleared
    2018-06-26

    (280 days)

    Product Code
    LKF
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing HangTian KaDi Technology R&D Institute

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HK-WQ-II are indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as lapacervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy. The HK-ZQ-I and HK-ZQ-II are intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.
    Device Description
    There are four versions of the subject device. HK-WQ-I and HK-WO-II have a curved central guide rod, while the HK-ZQ-I and HK-ZQ-II have a central guide rod which can be rotated (or "flexed") up or down using a dial on the handle. Each device is a sterile, disposable, single-patient use device which consists of a manipulator shaft with an inflatable intrauterine balloon at the proximal end. The intrauterine balloon is inflated by liquid via a standard syringe injected through the check valve. The internal injection tip of the manipulator shaft is open to allow direct intrauterine introduction of medicine liquid via the injector port. The device also incorporates a vaginal sealing balloon which is inflated by liquid via a standard syringe injected through the check valve to seal the vagina and maintain pneumoperitoneum. The location of the uterus can be adjusted by the handle. Each device version can be used with a cervical cup. During use, the open-end of the cup rests on the cervix. There are two versions of the cup- a ceramic version and a polyphenylene sulfite version. For both materials, the cup is available in four different sizes - 30mm, 35mm, 40mm and 46mm.
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    K Number
    K172789
    Device Name
    Specimen Retrieval Bag
    Manufacturer
    Beijing HangTian KaDi Technology R&D Institute
    Date Cleared
    2018-02-01

    (139 days)

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

    Beijing HangTian KaDi Technology R&D Institute

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.
    Device Description
    The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, opening support, outer introducer shaft, outer introducer handle, inner introducer handle, string and pull loop. The device is available in a series of models. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use.
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