Surgical instruments for pediatric, other sectors

Boulder, Colorado – 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.

Source: JustRight Surgical