Fortimedix Surgical said today it won FDA 510(k) clearance for its FMX314 single-port system for minimally invasive abdominal laparoscopic surgery.
Netherlands-based Fortimedix touted the newly cleared FMX314 as the “world’s 1st single-port surgery solution compatible with standard 15mm laparoscopic trocar,” saying the device will reduce port-site complications and reduce post-operative pain.
“We are very pleased to announce we have secured 510(k) clearance for our platform, as it signifies an important milestone in our quest to deliver on the promise of single-port surgery,” CEO Wout Bijker said in prepared remarks.
The company plans to introduce the device in the U.S. at the ACS Clinical Congress 2016 in Washington D.C. in mid-October.
In March, Fortimedix said it submitted an application for FDA 510(k) clearance for its FMX314 single-port surgery device.
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.