BOULDER, Colo., March 12, 2015 /PRNewswire/ -- JustRight Surgical, a micro-laparoscopic medical device company devoted to miniaturizing surgical instrumentation, has received CE mark approval for all of its FDA-cleared devices. CE marking indicates compliance with European Union regulations governing medical devices, no matter where in the world they are manufactured, and enables free movement within the European market. The company is poised to begin immediate distribution in select EU countries.
"This is an important milestone in our mission to provide right-sized instruments and technologies to general and pediatric surgeons around the world," said Russ Lindemann, president and CEO. "We have had continual requests for product outside the U.S. and the demand from Europe has been exceptional. We are very pleased to offer our smaller devices to the European surgical community and expand the clinical options available to them."
JustRight Surgical's devices—JustRight Vessel Sealing System (JustRight Generator and JustRight 3mm Sealer), JustRight 5mm Stapler and JustRight 5mm Reload—were developed under the guidance of domestic and international surgeons and are used in pediatric and general surgery where access is limited and visibility is reduced. These devices have been designed to facilitate less invasive surgical techniques; ultimately reducing scarring, pain and hospital stay.
By CE marking a product, a manufacturer declares that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA), the 28 Member States of the EU and European Free Trade Association (EFTA) countries, Iceland, Norway and Liechtenstein.
JustRight Surgical, LLC is privately held by local investors who have supported the company mission over the last four years.
Founded in 2010, JustRight Surgical's team of medical device professionals has an extensive patent portfolio and a record of developing breakthrough technologies that have transformed surgical procedures. JustRight Surgical exists to serve healthcare providers by developing precisely designed surgical instruments that allow access to confined spaces and delicate structures. By addressing this market, they are able to meet the specific needs of surgeons and promote the advancement of surgical approaches that reach beyond what traditional instruments have allowed. All of their products are designed and manufactured in the U.S. www.justrightsurgical.com.
SOURCE JustRight Surgical