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510(k) Data Aggregation
K Number
K063468Device Name
THE FUGO BLADE FOR DENTISTRY
Manufacturer
MEDISURG LTD.
Date Cleared
2007-04-18
(153 days)
Product Code
EKZ
Regulation Number
872.4920Why 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
K050933Device Name
FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
Manufacturer
MEDISURG LTD.
Date Cleared
2005-12-09
(239 days)
Product Code
NCR
Regulation Number
886.4100Why 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
K041019Device Name
THE FUGO BLADE FOR GLAUCOMA
Manufacturer
MEDISURG LTD.
Date Cleared
2004-10-08
(171 days)
Product Code
NCR
Regulation Number
886.4100Why 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
K001498Device Name
THE FUGO BLADE
Manufacturer
MEDISURG LTD.
Date Cleared
2000-08-10
(87 days)
Product Code
NCR
Regulation Number
886.4100Why did this record match?
Applicant Name (Manufacturer) :
MEDISURG LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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