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510(k) Data Aggregation

    K Number
    K083594
    Device Name
    EZ HSG CATHETER.FOAMSEAL CATHETER
    Manufacturer
    OBG PRODUCTS
    Date Cleared
    2009-07-21

    (228 days)

    Product Code
    LKF, CLA
    Regulation Number
    884.4530
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    Applicant Name (Manufacturer) :

    OBG PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Injection of fluid into the uterine cavity during Saline Infusion sonogram (SIS) & hysterosalpinogram (HSG). Following are some Clinical Indications: 1. Infertility. 2. Menorrahagia. 3. Dysmenorrhea. 4. Suspected Endometrial Polyp. 5. Uterine Fibroid. 6. Amenorrhea due to Uterine Synechea (Asherman Syndrome). 7. Congenital Uterine Anomaly.
    Device Description
    Foam Seal Catheter is a single channel catheter intended for use during Foam Seal Cadieter is a single endinsion sonogram. Foam Seal Catheter is a simplified version of double-channel balloon HSG catheter. This device has a single channel version of 1.6mm to 3mm in diameter and has a length of 370mm. Both ends of this catheter are open. The outer end has a luerlock device. A two way lock is attached to this end. The inner end is used to introduce fluid into the cavity of uterus. An introducer this cho. The finiter ens of agent is placed on its mid-segment. Both catherer and of an external caminate of plastic material. A cone-shaped foam component is attached close Calliula are made of placed in the cervical canal during the procedure. The foum to himel end so it can be placed find seal and to keep the catheter in place. Fluid media is injected into the cavity of uterus using this catheter with a syringe. Thich media is injected into ax carry of on the injected fluid. Radiology procedures of ultrasound examination is performed at this time and images of the cavity of the uterus is taken. There are several advantages to this device. This is a single chamel device and is taken. There are several advantages to the cervical canal and keeps the catheter in place without the need of an assistant.
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