PEAK Surgical Receives 510(k) Clearance To Market PEAK(R) Surgery System
PEAK Surgical, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its PEAK(R) Surgery System for cutting and coagulation of soft tissue during plastic and reconstructive, ENT (ear, nose and throat), gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures. The company also announced that it has initiated a series of clinical studies, called the PRECISE Studies (Pulsed Plasma Radiofrequency Energy to ReduCe Thermal Injury and Improve Surgical HEaling), to evaluate the use of the PEAK Surgery System in plastic, gynecologic and oncologic surgery.
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FDA Approves PEAK Surgical to market its Surgery System
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