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510(k) Data Aggregation
K Number
K052035Device Name
CANADY PLASMA PROBES
Manufacturer
CANADY TECHNOLOGY, LLC
Date Cleared
2005-08-31
(34 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
CANADY TECHNOLOGY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Canady Plasma Probes' intended use is for the delivery of argon gas plasma energy for argon enhanced coagulation of tissue.
Device Description
The Canady Plasma Probes are tubular instruments and are flexible. They are provided in various lengths and diameter sizes to accommodate the various size/types of endoscopes for a variety of applications (i.e. the treatment of various target tissues inside a patient). The Probes have applications in endoscopic surgical procedures such as upper and lower gastroenterology and bronchoscopy to provide a means of coagulation using electrosurgical current and argon gas.
The device consists of a connector which acts also as a handle for maneuvering the probe inside the working channel of an endoscope. Via an inner lumen of the Canady Plasma Probe argon gas is delivered to the operative site as well as an internal wire to carry high frequency (HF) electrosurgical current to a tungsten electrode tip at the end of the tubing. A ceramic tip insulates the thermal plastic tubing from the heat generated during coagulation. The electrode is positioned in the ceramic tip such that it cannot contact the patient's tissue during coagulation procedure.
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