Power Medical obtains FDA clearance
Power Medical Interventions of Langhorne, Pa., said that it has received U.S. Food and Drug Administration 510(k) marketing clearance for its i60 intelligent surgical instrument device.
The product is used for open and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection and transection, creation of anastomoses and for open occlusion of the heart's left atrial appendage, according to Power Medical.
The i60 intelligent surgical instrument is controlled by drive motors, motor control circuits and clinician-feedback technology that have been miniaturized and integrated into the handpiece and is operated with digital controls located in the handle. The i60 does not require a power console or a flexible shaft, the company said.
The product is used for open and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection and transection, creation of anastomoses and for open occlusion of the heart's left atrial appendage, according to Power Medical.
The i60 intelligent surgical instrument is controlled by drive motors, motor control circuits and clinician-feedback technology that have been miniaturized and integrated into the handpiece and is operated with digital controls located in the handle. The i60 does not require a power console or a flexible shaft, the company said.