About This 510(k) Submission
K062750 is an FDA 510(k) clearance for the WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030, a Stent, Metallic, Expandable, Duodenal (Class II — Special Controls, product code MUM), submitted by Boston Scientific Corp (Marlborough, US). The FDA issued a Cleared decision on December 4, 2006, 81 days after receiving the submission on September 14, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.