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510(k) Data Aggregation
K Number
K100258Device Name
ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200
Manufacturer
Date Cleared
2010-04-28
(90 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
WICKIMED SUPPLY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The electrosurgical pencil with electrode is a handheld accessory for high voltage high frequency electrosurgical devices. Normally, it operates under a frequency range of 0.2 – 5 MHz with a maximum peak-to-peak voltage level of 9000V. The maximum power of the device is under 400watts.
By pressing the Yellow and Blue buttons on the pencil, it performs to CUT tissue and to COAGULATE tissue to stop bleeding during surgical operation. Making use of suitable detachable electrode, it fits various kind of application requirement.
Device Description
The electrosurgical pencil with electrode is a handheld accessory for high voltage high frequency electrosurgical devices. Normally, it operates under a frequency range of 0.2 – 5 MHz with a maximum peak-to-peak voltage level of 9000V. The maximum power of the device is under 400watts.
By pressing the Yellow and Blue buttons on the pencil, it performs to CUT tissue and to COAGULATE tissue to stop bleeding during surgical operation. Making use of suitable detachable electrode, it fits various kind of application requirement.
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