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510(k) Data Aggregation

    K Number
    K253327
    Device Name
    HANAROSTENT Esophagus Upper (CCC)
    Manufacturer
    M.I. Tech Co., Ltd.
    Date Cleared
    2025-10-30

    (30 days)

    Product Code
    ESW
    Regulation Number
    878.3610
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K201160
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HANAROSTENT® Esophagus Upper (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.

    Device Description

    This self-expanding tubular prosthesis is designed to maintain patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and an over the wire (OTW) delivery device.

    The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, radiopaque markers made of gold wire, fully covered silicone membrane, and one repositioning lasso at each end of the stent made of polymeric materials. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device and expanded in the body by pulling the outer sheath of the delivery device. The HANAROSTENT® Esophagus Upper (CCC) is intended for single use only.

    AI/ML Overview

    N/A

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