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510(k) Data Aggregation
K Number
K032969Device Name
HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE
Manufacturer
HELICA INSTRUMENTS, LTD
Date Cleared
2004-02-04
(134 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
HELICA INSTRUMENTS, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a helium gas electrosurgical cutting and coagulator for use in all soft tissue surgery- laparoscopic, endoscopic and open.
Device Description
The device is a helium gas electrosurgical coagulator for use in all soft tissue surgery-laparoscopic, endoscopic and open. It consists of two parts: A power generator control unit with a Helium gas supply and an application probe. An ionised gas plasma flame is generated in a controlled Helium gas flow at the end of a 4mm PTFE application tube (the probe). This produces a corona-type flame issuing from the open end of the probe with a high electron temperature but low molecular temperature of about 20C. When the probe is brought close (within 3 mm) to a surface connected to earth - such as human tissue - the corona-type flame changes to an arc discharge flame with a temperature of approx. 800C. The inert Helium gas flow in which the discharge takes place protects the area of discharge and minimises oxidation. This plasma flame can be used to stop blood flow from damaged tissue by cauterisation. The electrical generator provides an alternating current at a fixed frequency in the kilo hertz range with a power supply range of between 2 and 30W. The new probe is the LTC. This is a cutting probe where the 4mm PTFE tube retracts, exposing the point which is approximately 8-10mm long. This probe works by using the Corona flame passing between the point and the tissue at the nearest point which could be on the side of the probe. The point area which is hot then cuts through the tissue and cauterises small blood vessels as it passes through.
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