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510(k) Data Aggregation

    K Number
    K050933
    Device Name
    FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
    Manufacturer
    MEDISURG LTD.
    Date Cleared
    2005-12-09

    (239 days)

    Product Code
    NCR
    Regulation Number
    886.4100
    Why did this record match?
    Product Code :

    NCR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fugo Blade ® for peripheral iridotomy is indicated for intraocular creation of iridotomies.
    Device Description
    The Fugo Blade for PI is an electrosurgical device that is powered by the electromagnetic (EM) energy from flashlight size batteries. This energy is conditioned, tuned (9,8 x 10 6 Hz) and focused on a thin, blunt cutting filament. Moreover, EM energy from flashlight size ("C" cell) batteries is fed into a proprietary electronic network system which is activated by the surgeon with an on/off switch. This electronic system is fed EM energy from the battery energy supply source then conditions, tunes (9.8 x 10 6 ) and focuses this EM energy into a 50-100 micron column of EM energy surrounding a blunt 100 micron diameter cutting filament at the end of the Fugo Blade hand piece. This column of EM field energy is capable of reacting with iris tissue. This column of EM field energy causes the molecular bonds in the iris tissue which comes in contact with the EM field to ionize momentarily and thereby break apart, a condition that physicists refer to as a momentary "plasma formation". In this way, the molecular lattice of the iris is broken down, thereby creating a peripheral iridotomy.
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    K Number
    K041019
    Device Name
    THE FUGO BLADE FOR GLAUCOMA
    Manufacturer
    MEDISURG LTD.
    Date Cleared
    2004-10-08

    (171 days)

    Product Code
    NCR
    Regulation Number
    886.4100
    Why did this record match?
    Product Code :

    NCR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sclerostomy for the treatment of primary open- angle glaucoma where maximum tolerated medical therapy and trabeculoplasty have failed.
    Device Description
    The entire electronic system of Fugo Blade for thermocauterization in glaucoma is equivalent to the predicate system. The only difference in the two systems is the geometry of the disposable incision tips as delineated in detail above.
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    K Number
    K001498
    Device Name
    THE FUGO BLADE
    Manufacturer
    MEDISURG LTD.
    Date Cleared
    2000-08-10

    (87 days)

    Product Code
    NCR
    Regulation Number
    886.4100
    Why did this record match?
    Product Code :

    NCR

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

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