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510(k) Data Aggregation

    K Number
    K253987

    Validate with FDA (Live)

    Device Name
    BARE Wireguided Balloon Dilation Catheter (1235)
    Manufacturer
    GIE Medical
    Date Cleared
    2026-03-13

    (91 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    12 - 999
    Reference & Predicate Devices
    K180418,K112994
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BARE Wireguided Balloon Dilation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilation of the Sphincter of Oddi with or without prior sphincterotomy.

    Device Description

    The BARE Wireguided Balloon Dilation Catheter is an over-the-wire, through the scope, dual lumen balloon catheter compatible with 0.035" guidewires with a distally mounted semicompliant inflatable balloon and an atraumatic tapered tip. The multistage balloon provides three distinct diameters at three corresponding pressures. The device has two radiopaque marker bands, visible under fluoroscopy, to aid in balloon positioning.

    The BARE Wireguided Balloon Dilation Catheter is available in multiple balloon diameters and balloon lengths with a catheter shaft length of 180 cm or 240 cm. A balloon compliance chart with inflation pressures and balloon diameters is located on the foil pouch label and on the information tag attached to the catheter shaft.

    AI/ML Overview

    N/A

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