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510(k) Data Aggregation

    K Number
    K250659

    Validate with FDA (Live)

    Device Name
    LoFric Origo
    Manufacturer
    Wellspect AB
    Date Cleared
    2025-09-26

    (205 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K122078
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LoFric Origo is indicated for short- and long-term bladder management with intermittent urinary catheterization.

    Device Description

    The subject device: LoFric® Origo™ is a range of sterile, single-use, urinary catheters designed as an intermittent pathway for drainage of the bladder. The catheters, designed to accommodate the individual anatomy of male users, are available in various lengths and French sizes, and come in three tip designs: Nelaton (straight tip), Flexible (straight ball-shaped tip), and Tiemann (Coudé tip). Each catheter is individually packaged together with an adjustable insertion grip, or an extendable protective sleeve attached to the catheter along with a sterile water sachet (packet). The adjustable insertion grip or the extendable protective sleeve are provided to minimize touching the catheter shaft directly during insertion and retraction. The water sachet is provided for wetting of the hydrophilic surface and is to be broken immediately before use in order to soak the tubing.

    AI/ML Overview

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