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510(k) Data Aggregation

    K Number
    K080317
    Device Name
    ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL
    Manufacturer
    SYNTHEON LLC
    Date Cleared
    2008-04-29

    (83 days)

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

    SYNTHEON LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoLok™ is indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy.
    Device Description
    The EndoLok™ is a non-sterile, single-use device designed to be used in conjunction with standard colonoscopes. It consists of a handle with a trigger mechanism that is used to grip the colonoscope shaft.
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