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510(k) Data Aggregation
K Number
K082584Device Name
GIVEN ELECTROSURGICAL NEEDLE
Manufacturer
Date Cleared
2009-10-28
(415 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
TRIPPS COURT ENTERPRISES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Given Electrosurgical Needle is used to apply electrosurgical current directly into a spider vein located within the skin. The electrosurgical current destroys the spider vein.
Device Description
The Given Electrosurgical Needle is a single patient use needle electrode for use in monopolar electrosurgical handpieces. The skin which is usually anesthetized with a topical and/or injectable anesthetic. The monopolar generator is set at the cutting mode to 1.5 to 1.75 Watts. The needle is introduced into the vein located within the skin. The current is then applied with destruction of the vein while the insulation protects the surrounding tissue. The needle is withdrawn and additional veins are then treated in a similar fashion. The needle is made of Tungsten Carbide and the insulation is Parylene-C which are both biocompatible materials that have been used extensively in electrosurgical electrodes.
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