510(k) approval for General Surgical Innovations:
This article was originally published in Clinica
Executive Summary
General Surgical Innovations' range of Spacemaker tissue dissection products has received 510(k) approval for its extended use which will include surgical use involving access to the spine and long-bone plating. Other applications are thoracoscopic procedures involving exposure and dissection of nerves, blood vessels and other tissues of the chest walls. The device produce surgical working space by separating natural tissue planes without the need to use blunt dissection as in conventional open surgery.