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510(k) Data Aggregation

    K Number
    K212430
    Device Name
    BONREE Nelaton Catheter
    Date Cleared
    2022-04-29

    (268 days)

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

    Bonree Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BONREE Nelaton Catheter is used for clean intermittent catheterization (CIC) treatment. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old) for draining urine from the bladder.
    Device Description
    The BONREE Nelaton Catheter is sterile, single patient use, urinary drainage catheter that is made from PVC. The catheter is comprised of shaft, tip and funnel. It has two drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The tip is available in a straight or coude configuration. The tip of the catheter passes through the urethra into the bladder to allow urine to drain into the eyelets and then through the catheter shaft, exiting through the funnel. The BONREE Nelaton Catheters are produced with two different models—Straight Tip and Coude Tip. Both models will be available for male, female and pediatric. The difference between two models is the tip design. For Straight Tip catheters, the dimensions range from 6Fr to 22Fr which is a range of 2.0 mm to 7.33 mm in Outer Diameter with a straight tip shape. For Coude Tip catheters, the dimensions range from 10Fr to 18Fr which is a range of 3.33 mm to 6.0 mm in Outer Diameter with a bent catheter tip shape. The difference between the Female and Male type is the tube lengths. The Male type is offered in a 400mm tube overall length and 370mm tube effective length, whereas the Female type is offered in a 200mm tube overall length and 170mm tube effective length.
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