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510(k) Data Aggregation

    K Number
    K240364
    Device Name
    RELIEEV Uterine Manipulator Injector (CUMI 5.0)
    Manufacturer
    LI Medical Corporation Ltd.
    Date Cleared
    2024-10-16

    (253 days)

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

    LI Medical Corporation Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of the RELIEEV Uterine Manipulator Injector is indicated in Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty procedures where manipulation of the uterus is required.
    Device Description
    The "RELIEEV" Uterine Manipulator Injector is intended to be used during medical procedures where manipulation of the uterus or injection of fluids into the uterine lumen are needed. This device is a sterile, single use product consisting of a plastic (PVC) insertion tube that includes two lumens, one for inflation of a 10 mL intrauterine balloon (cuff) at the distal end of the insertion tube via the inflation valve using the provided 10 mL syringe and the other for injection of fluid through a distal end-port using a user-provided syringe via the Leur fitting. The device also includes a movable/removable rigid handle that allows alteration of the device insertion depth and includes a cervical stop, laser etched depth markings to aid in setting the insertion depth, and a pilot balloon to assess maintenance of cuff inflation. The device is curved to facilitate forward uterine manipulation. The device has an overall length of 36 cm and an outer diameter of the catheter component of 5.0 mm. When inflated with 10 mL of air, the balloon has a diameter of 23.0-24.9 mm.
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    K Number
    K240434
    Device Name
    RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
    Manufacturer
    Li Medical Corporation Ltd.
    Date Cleared
    2024-09-25

    (224 days)

    Product Code
    HHK
    Regulation Number
    884.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    Li Medical Corporation Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) is used to remove samples of materials from the uterus and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain tissue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
    Device Description
    The "RELIEEV" Suction Curette is a sterile, disposable, single-use device used to obtain a sample from the uterine mucosal lining. It is available in two models – Flexible 3.0 and Standard 3.6 with outer diameters of 3.0 mm and 3.6 mm respectively. The device consists of a tube and piston made of polypropylene (PP) with a silicone O-ring. The subject device is packaged in medical paper grade pouch (60g).
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