510(k) K062750

WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 by Boston Scientific Corp — Product Code MUM

K062750 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030". The FDA issued a decision of Substantially Equivalent on December 4, 2006. The device falls under product code MUM (Stent, Metallic, Expandable, Duodenal), a Class II device regulated under 21 CFR 878.3610. Boston Scientific Corp has at least 10 other 510(k) clearances on record.