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510(k) Data Aggregation

    K Number
    K063468
    Device Name
    THE FUGO BLADE FOR DENTISTRY
    Manufacturer
    MEDISURG LTD.
    Date Cleared
    2007-04-18

    (153 days)

    Product Code
    EKZ
    Regulation Number
    872.4920
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDISURG LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fugo Blade system is intended for incision, excision, ablation, vaporization and hemostasis of oral soft tissue e.g. excisional and incisional biopsies; exposure of unerupted teeth; fibroma removal; frenectomy and frenotomy; gingival troughing for crown impressions; gingiyoplasty: gingivectomy; gingival incision and excision; hemostasis; implant recovery; incision and drainage of abscess; leukoplakia; operculectomy; oral papillectomies; pulpotomy; pulpotomy as an adjunct to root canal therapy; reduction of gingival hypertrophy; soft tissue crown lengthening; secular debridement; treatment of aphthous ulcers; vestibuloplasty; biopsy incision and excision; and lesion (tumor) removal.
    Device Description
    The Fugo Blade for dentistry is an electrosurgical device that is powered by the electromagnetic (EM) energy from flashlight size batteries. This energy is conditioned, tuned (9.8+/- 2.0 x 106 Hz) and focused on a thin blunt cutting filament. Moreover, the 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 it in a proprietary fashion and transfers it to the surgeon cutting filament. This column of EM energy is capable of reacting with tissue. This column of EM energy causes the molecular bonds in the tissue which come in contact with the EM field to ionize and thereby break apart, a condition that plasma physicists refer to as "plasma formation". In this way, the molecular lattice of the tissue is broken into micro-fragments, thereby creating an incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.
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    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?
    Applicant Name (Manufacturer) :

    MEDISURG LTD.

    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?
    Applicant Name (Manufacturer) :

    MEDISURG LTD.

    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?
    Applicant Name (Manufacturer) :

    MEDISURG LTD.

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

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