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510(k) Data Aggregation

    K Number
    K213251
    Device Name
    HANAROSTENT Esophagus Asymmetric (CCC)
    Manufacturer
    M.I.Tech Co., Ltd.
    Date Cleared
    2021-11-18

    (49 days)

    Product Code
    ESW
    Regulation Number
    878.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.I.Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HANAROSTENT® Esophagus Asymmetric (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 a delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire with fully covered silicone membrane, and 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 Asymmetric (CCC) is intended for single use only.
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    K Number
    K202973
    Device Name
    HANAROSTENT Benefit Biliary (NNN)
    Manufacturer
    M.I.Tech Co., Ltd.
    Date Cleared
    2021-05-11

    (223 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.I.Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HANAROSTENT® Benefit™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
    Device Description
    The HANAROSTENT® Benefit™ Biliary (NNN) is a self-expanding tubular prosthesis designed to maintain patency of biliary obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire. 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 stent and delivery device are provided sterile and are intended for single use only.
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    K Number
    K190141
    Device Name
    HANAROSTENT LowAx Colon/Rectum (NNN)
    Manufacturer
    M.I.Tech Co., Ltd.
    Date Cleared
    2019-03-07

    (37 days)

    Product Code
    MQR
    Regulation Number
    878.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.I.Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
    Device Description
    This self-expanding tubular prosthesis designed to maintain patency of colorectal obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire and the delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system. The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is intended for single use only.
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    K Number
    K183396
    Device Name
    HANAROSTENT FASTTM Biliary (NNN)
    Manufacturer
    M.I.Tech Co., Ltd.
    Date Cleared
    2019-02-11

    (66 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.I.Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HANAROSTENT® FAST™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
    Device Description
    This self-expanding tubular prosthesis is designed to maintain patency of bile duct obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, and the delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system, and expanded in the body by pulling the outer sheath of the delivery system. The HANAROSTENT® FAST™ Biliary (NNN) is intended for single use only.
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