Netherlands-based medical device company Fortimedix Surgical said today it submitted an application for FDA 510(k) clearance for its FMX314 single-port surgery device.
The company said its FMX314 is the “world’s 1st” single-port surgery solution compatible with standard 15mm laproscopic trocar. The device “closely mimicks” conventional multi-port laparoscopy to allow surgeons to comfortably perform procedural steps, Fortimedix said.
“We are very pleased to announce our submission with the FDA, as it represents an important milestone towards market introduction of FMX314 in the United States, which is expected in the fourth quarter of this year,” global business dev veep Marc van de Graaf said in a press release.
Fortimedix is a developer of endovascular stents that has worked for years as a contract manufacturer of stent technology, according to the company’s website.
“With its unique sizing and ease-of-use, we believe FMX314 will deliver on the promise of single-port surgery, elevating the standard of care in laparoscopy,” Van de Graaf said in prepared remarks.