PEAK Surgical Receives 510(k)

PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, announced that the U.S. Food and Drug Administration has granted the company 510(k) clearance to market its PEAK(R) Surgery System for use in general surgery. The PEAK Surgery System combines the PULSAR(TM) Generator, which supplies pulsed plasma radio frequency energy, with the PEAK PlasmaBlade(TM) 4.0, a low-temperature surgical cutting and coagulation tool. This tissue dissection system will be commercially available next month."With the introduction of the PlasmaBlade, general surgeons now have access to a single surgical tool that cuts tissue as precisely as a scalpel and controls bleeding as effectively as traditional electrosurgery without causing extensive collateral thermal damage to tissues," said John Tighe, chief executive officer of PEAK Surgical.
PlasmaBlade
PEAK Surgical’s first cutting and coagulation tool, the PEAK PlasmaBlade, is a disposable device that offers the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage.The PEAK PlasmaBlade is based on proprietary pulsed plasma technology. This technology represents an evolutionary leap in the advancement of radiofrequency surgical technologies, which originated with traditional electrosurgery and progressed to plasma-mediated energy devices.