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510(k) Data Aggregation

    K Number
    K251468

    Validate with FDA (Live)

    Device Name
    Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)
    Manufacturer
    Hollister Incorporated
    Date Cleared
    2025-10-03

    (143 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K233524
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

    Note: 8 inch Sleeved IC 3 Pocket consists of a subset of the original population:

    8 inch Sleeved IC 3 Pocket
    This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.

    Device Description

    Sleeved IC 3 (not finalized) catheters are E-beam sterilized hydrophilic-coated, single-use catheters. The subject device has two drainage eyelets that are used to manage urinary incontinence.

    The device is inserted into the urethra to drain urine from the bladder.

    The device is available in 16 inch and 8-inch lengths. The device is available in various Fr sizes ranging from Fr 08 through Fr 16. The catheter is made from Thermo-plastic Elastomer (TPE), (not made with phthalates, not made with PVC). The catheter sleeve is manufactured from Low Density Polyethylene (LDPE). The catheter sleeve allows for the user to grip the catheter anywhere along the length during insertion.

    The device is packaged in a foil which was designed to be easy to open and to facilitate access to the catheter. The device is contained in a primary package that consists of both the catheter assembly and the hydration fluid. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid. The device is available with and without the integrated urine collection bag. The device is available in straight and pocket packaging configurations.

    The subject device covers several configurations:
    • Sleeved IC 3 straight (SWT) is an intermediate catheter in a straight configuration
    • Sleeved IC 3 Plus is the same catheter with an attached urine bag
    • Sleeved IC 3 Pocket has the catheter coiled up for a smaller footprint
    • Sleeved IC 3 Plus Pocket is the same coiled catheter with an attached urine bag

    The devices are surface devices with mucosal membrane contact with prolonged contact duration (> 24 hours to 30 days) due to cumulative use. The devices are intended to be used in both professional healthcare facilities and the home environment.

    AI/ML Overview

    N/A

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