Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K160877
    Device Name
    United Urologics Closed System Catheter
    Date Cleared
    2016-05-20

    (51 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROBLING MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    United Urologics Closed System Intermittent Catheterization kit is intended to be used to drain urine from the patient's bladder into a collection bag.
    Device Description
    The United Urologics Closed System Catheter is a pre-lubricated sterile, single use, disposable, urinary incontinence device designed to drain urine from the patient's bladder into a urine collection bag. The device is manufactured of a flexible tube with a smooth radius, atraumatic tip to facilitate introduction into the urethra. The catheter is manufactured with drainage holes in the side of the tubing closest to the tipped end of the catheter in order to allow drainage of urine from the bladder through the central lumen of the catheter tube. The catheter is provided with a funnel bonded to the end of the catheter tube opposite the tipped end. The catheter is prelubricated with a water soluble lubricant and sealed in a urine collection bag. It is designed with a molded silicone tip at the top of the bag which acts as an introducer sheath for the tip of the catheter. This introducer and holding mechanism on the inside of the bag, provide a mechanism for inserting and advancing the catheter to the bladder without direct hand contact to the catheter. The device may be used by the patient or caregiver in a healthcare facility, hospital, and home or public restroom facility to facilitate drainage of urine from the bladder.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1