510(k) K980113

WALLSTENT ENTERAL ENDOPROSTHESIS by Boston Scientific Scimed, Inc. — Product Code MUM

K980113 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "WALLSTENT ENTERAL ENDOPROSTHESIS". The FDA issued a decision of Substantially Equivalent on April 3, 1998. The device falls under product code MUM (Stent, Metallic, Expandable, Duodenal), a Class II device regulated under 21 CFR 878.3610. Boston Scientific Scimed, Inc. has at least 10 other 510(k) clearances on record.