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510(k) Data Aggregation
K Number
K082505Device Name
KLS MARTIN ELECTROSURGICAL INSTRUMENTS
Manufacturer
Date Cleared
2009-06-12
(287 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
KL MARTIN L.P.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.
KLS Martin Bipolar Instruments with Handles and Exchangeable Electrodes are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.
KLS Martin marLap Bipolar Coagulation instruments are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.
KLS Martin Bipolar Forceps/Non-Stick are design to grasp, manipulate and coagulate selected tissue.
KLS Martin Electrosurgical Instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures
KLS Martin Electrosurgical cables are intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar electrosurgical generator to a bipolar instrument.
Device Description
The KLS Martin Electrosurgical Instruments are surgical instruments that allow the surgeon to cauterize and coagulate tissue by passing a electrical current that is provided by a electrosurgical generator. The instruments are insulated to isolate the user from the current. The KLS Martin Electrosurgical Instruments are manufactured in a variety of shapes and sizes to allow the operating surgeon choices for optimum efficiency.
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