It is with great pleasure that we announce the acceptance of the Livac 510(k) submission by the FDA.

The LiVac Retractor System was cleared by the US Food and Drug Administration (FDA) on 20th October 2016 with “no questions asked” and with the original acceptance notification received on 1st September, was approved within 2 months and in a much shorter time frame than originally expected.

The approved indication for the device in the US is “an organ and tissue retractor for use in laparoscopic procedures to elevate organs and tissue, to provide improved access and visualisation of surgical sites”. This means the LiVac Retractor System is approved for retraction of the liver and other organs in the US market.

The 510(k) approval now allows Livac to sell the LiVac Retractor System in the US laparoscopic surgical market. The US market is one of LiVac’s largest international markets and the company will now pursue negotiations with multi-national medical companies for the US distribution rights.