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510(k) Data Aggregation

    K Number
    K013712
    Device Name
    ENTERYX INJECTOR
    Manufacturer
    ENTERIC MEDICAL TECHNOLOGIES
    Date Cleared
    2002-05-31

    (204 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTERIC MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Enteric Medical Technologies Enteryx™ Injector Disposable Endoscopic Injection Catheter is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varices and for submucosal dye marking in the upper GI tract.
    Device Description
    Enteryx™ Injector Disposable Endoscopic Injection Catheter
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    K Number
    K002778
    Device Name
    ENTERIC INJECTION CATHETER WITH IRRIGATION
    Manufacturer
    ENTERIC MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2000-11-22

    (77 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTERIC MEDICAL TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000646
    Device Name
    DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
    Manufacturer
    ENTERIC MEDICAL TECHNOLOGIES
    Date Cleared
    2000-04-13

    (48 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTERIC MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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