Covidien received 510(k) clearance to market Covidien SILS(TM)


Covidien, a leading global provider of healthcare products, announced that its Surgical Devices business unit has received 510(k) clearance from the U.S. Food and Drug Administration to market the Covidien SILS(TM) Port Multiple Instrument Access Port for laparoscopic surgeries through a single incision.

The SILS(TM) Port is a single, flexible port that can be fitted through a small incision in the umbilicus which results in a single "hidden scar," a cosmetic advance over the multiple visible scars associated with standard multi-port laparoscopy. The port has the capacity for up to three laparoscopic instruments.

Scott Flora, President, Surgical Devices, Covidien said, SILS(TM) Port is the first device specifically indicated for multiple instrument access to the abdomen through a single incision. We led the first surgical revolution with multi-port laparoscopic surgery and Covidien is now leading the way again with SILS(TM) procedures and the new SILS(TM) Port, innovations that offer surgeons an immediate advancement in patient care he added.