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510(k) Data Aggregation

    K Number
    K083275
    Device Name
    PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
    Manufacturer
    MAX ENDOSCOPY INC.
    Date Cleared
    2009-06-09

    (215 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAX ENDOSCOPY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PRECISION Endoscopic Infrared Coagulator (model 5100) with single-use disposable MAXi-guide flexible light guide (model 5100-240-3.2) is intended for treatment of hemorrhoids by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
    Device Description
    Not Found
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    K Number
    K080764
    Device Name
    SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100
    Manufacturer
    MAX ENDOSCOPY INC.
    Date Cleared
    2008-05-06

    (49 days)

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

    MAX ENDOSCOPY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The single-use disposable device is intended to allow the physician to temporarily increase the stiffness of a colonoscope when extra rigidity is required.
    Device Description
    Not Found
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