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

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
K250663	Taewoong Medical Co., Ltd.	Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent	03/31/2025
K223067	Taewoong Medical Co., Ltd.	Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent	06/14/2023