FDA 510(k) Applications for Medical Device Product Code "MUM"
(Stent,Metallic,Expandable,Duodenal)

FDA 510(k) Number Applicant Device Name Decision Date
K062750 BOSTON SCIENTIFIC CORP. WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 12/04/2006
K980113 BOSTON SCIENTIFIC SCIMED, INC. WALLSTENT ENTERAL ENDOPROSTHESIS 04/03/1998
K101530 COOK IRELAND LTD EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D 03/29/2011
K163468 Cook Ireland Ltd. Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered 05/04/2017
K223067 Taewoong Medical Co., Ltd. Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent 06/14/2023


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