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510(k) Data Aggregation

    K Number
    K251178

    Validate with FDA (Live)

    Date Cleared
    2026-01-02

    (261 days)

    Product Code
    Regulation Number
    876.5130
    Age Range
    0 - 150
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ready-to-Use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for individuals (men, women, pediatrics) who are unable to promote natural urine flow or have a significant volume of residual urine following a natural bladder-voiding episode.

    The catheter is inserted into the urethra to reach the bladder, allowing urine to drain and ensuring bladder emptying.

    Device Description

    Ready to use Nelaton Catheter is a sterile, single use catheter, intended to be inserted through the urethra to the bladder for intermittent urine drainage. The catheters are available in a variety of lengths and French sizes to accommodate individual anatomy of adult and pediatric patients (including males and females).

    The catheter is made of polyurethane, and is not made with PVC. It is prelubricated with a hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel at the proximal end can be connected to a urine collection container. There is a gripper on the catheters for adult males (length of 40cm), which serves as protection from the user's touch and aids the user during insertion.

    The catheter is sealed in a foil pouch with the hydration liquid (distilled water) in one compartment, so the coated catheter is lubricated by direct contact with the hydration liquid and can be ready to use. Ready to use Nelaton Catheter is sterilized by E-beam irradiation, and the shelf life is 3 years.

    AI/ML Overview

    N/A

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