www.fdanews.com/articles/114739-fda-clears-safestitch-dilator
FDA Clears SafeStitch Dilator
February 18, 2009
SafeStitch Medical has received FDA 510(k) clearance for its Smart Dilator. Used in esophageal dilation procedures, the device indicates the pressure level being applied at the stricture to help simplify and shorten the process. The product also is designed to reduce the incidence of esophageal perforation, a dangerous complication, according to the company.