‘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,’ commented Mr. Wout Bijker, CEO of Fortimedix Surgical.
FMX314 is the world’s first single-port surgery solution compatible with a standard 15mm laparoscopic trocar, promising fewer port-site complications, less post-operative pain, faster recovery and exceptional cosmesis. Emulating conventional, multi-port laparoscopy makes FMX314 easy to use and enables surgeons to perform procedural steps ergonomically, allowing for a comfortable and secure single-port approach.
Market introduction in the United States is scheduled during the upcoming ACS Clinical Congress 2016 (October 16 – 20) in Washington, DC.
Note: FMX314 is the engineering code name for symphonX™ used during the pre-commercial phase.