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news.Covidien has announced that its Surgical Devices business unit has received FDA 510(k) clearance to market the Covidien SILS Procedure Kit, indicated for Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures.
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The Covidien Single-Incision Laparoscopic Surgery (SILS) Procedure Kit is scheduled for commercialization in the summer of 2008, and customized kit solutions are also forthcoming to enable SILS procedures for general surgery, urologic, gynecologic and bariatric surgery applications.
According to the company, the devices in the kit can be used by surgeons to conveniently perform laparoscopic procedures through a single skin incision located within the patient’s umbilicus, or belly button. The kit features several advanced articulating instruments and access ports, which enable improved access to the surgical site and maneuverability for tissue dissection and retraction.
Scott Flora, president, Surgical Devices, Covidien, said: “Covidien’s introduction of products for SILS™ is an important step toward our ultimate goal of enabling incision-less surgery that will improve patient outcomes.”