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510(k) Data Aggregation

    K Number
    K222798
    Device Name
    Rejoni Intrauterine Catheter
    Manufacturer
    Rejoni, Inc.
    Date Cleared
    2022-12-16

    (91 days)

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

    Rejoni, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rejoni Intrauterine Catheter is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG. the Rejoni Intrauterine Catheter can be used for evaluation of tubal patency. The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).
    Device Description
    The Rejoni Intrauterine Catheter is a sterile, single lumen uterine catheter that facilitates access to the uterus to deliver fluids during Hysterosalpingography (HSG) or Sonohysterography (SHG). The Rejoni Intrauterine Catheter consists of an inner shaft and an additional support sheath over the proximal portion of the catheter shaft to provide additional stiffness. A repositionable stopper ("acom") is connected to the support sheath, which is placed on the catheter shaft, and can be repositioned from 0 cm up to 10 cm from the distal tip of the catheter. The stopper maintains placement of the catheter against the external cervical os during the procedure, and a luer lock-style adapter on the proximal end is available for compatibility with syringes. The distal end contains a straight through hole for delivery of fluids during the procedure.
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