PEAK Surgical Receives 510(k) Clearance To Market PEAK(R) Surgery System

admin — Fri, 02 Jan 2009 13:36:44 +0000

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.

FDA Approves PEAK Surgical to market its Surgery System

admin — Tue, 02 Sep 2008 20:58:41 +0000

The U.S. Food and Drug Administration has granted PEAK Surgical, Inc 510(k) clearance to market its PEAK(R) Surgery System for use in general surgery. The medical device company has developed this new tissue dissection system based on a proprietary technology. It combines the PULSAR Generator, which supplies pulsed plasma radiofrequency energy, with the PEAK PlasmaBlade 4.0, a low-temperature surgical cutting and coagulation tool. This will make the cutting process more accurate and control bleeding. The new surgery system will be available in the market by next month.

Surgical Product Guide » PEAK Surgical

PEAK Surgical Receives 510(k) Clearance To Market PEAK(R) Surgery System

FDA Approves PEAK Surgical to market its Surgery System