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510(k) Data Aggregation
K Number
K142868Device Name
5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin
Manufacturer
Purple Surgical International Limited
Date Cleared
2014-11-21
(51 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Purple Surgical International Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
use in general laparoscopic surgery requiring the use of monopolar electrosurgical cutting and/or coagulation.
Device Description
The Laparoscopic Electrodes are electrosurgical devices, used for a variety of laparoscopic procedures through a port, for coaqulation and transection of soft tissue and vessels by use of high frequency electric current. The Monopolar cable provides the electrical connection between the Electrode and a suitable electrosurgical generator. Both the Laparoscopic Electrodes and Monopolar cables are single patient use and supplied sterile to healthcare professionals only.
The Laparoscopic Electrodes each consist of a fully insulated, stainless steel shaft. 33cm in length. incorporating three different available types of thermally conductive, insulated metal tip electrodes for conveyance of HF electric current and operated via an ergonomic plastic handle for tactile feedback during surgery procedures. The device should be used through a surgical cannula that has an internal diameter of greater than 5mm.
The Monopolar cable is an insulated copper cord for conveyance of high frequency electrosurgical energy that connects between the HF diathermy connector situated at the end of the handle of the Laparoscopic Electrode and the specified output terminal of a suitable electrosurgical generator (not supplied), with a neutral electrode (not supplied) required to complete the electrosurgery circuit. They are intended for use at a maximum rated voltage of 5.5KVpeak. Coagulation and cutting is achieved using electrosurqical energy supplied via various types of electrosurgical generator.
The associated accessories required to complete the electrosurgical circuit include: Electrosurgical generator. Neutral Electrode.
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