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The PEAK® Surgery System has been granted FDA 510(k) clearance for cutting and coagulation of soft tissue during plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures. The PEAK Surgery System, which received initial FDA clearance for use in general surgery in July 2008, includes the PEAK PlasmaBlade™ family of disposable surgical cutting and coagulation devices. The PlasmaBlade tissue dissection devices are used in conjunction with PEAK's PULSAR™ Generator, which provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding. The PlasmaBlade offers the exacting control of a scalpel and the coagulation of traditional electrosurgery without causing extensive collateral damage.
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