FDA 510(k) Applications for Medical Device Product Code: MQR (Stent, Colonic, Metalic, Expandable)

FDA 510(k) Applications for Medical Device Product Code "MQR"
(Stent, Colonic, Metalic, Expandable)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K030769	BOSTON SCIENTIFIC CORP.	ULTRAFLEX PRECISION COLONIC STENT	07/14/2003
K061877	BOSTON SCIENTIFIC CORP.	WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM	09/15/2006
K042065	BOSTON SCIENTIFIC CORP.	WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM	09/30/2004
K991056	BOSTON SCIENTIFIC CORP.	WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM	06/22/1999
K000281	BOSTON SCIENTIFIC CORP.	WALLSTENT ENTERNAL PROSTHESIS	05/12/2000
K060323	Boston Scientific Corporation	ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380	05/12/2006
K200257	Boston Scientific Corporation	WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System	04/17/2020
K201159	Boston Scientific Corporation	WallFlex Colonic Stent System with Anchor Lock Delivery System	08/17/2020
K954290	BOSTON SCIENTIFIC SCIMED, INC.	WALLSTENT ENTERAL ENDOPROTHESIS	07/10/1996
K990504	C.R. BARD, INC.	MEMOTHERM COLORECTAL STENT	03/16/2000
K113510	COOK IRELAND LTD	EVOLUTION COLONIC STENT SYSTEM	05/17/2012
K183616	M.I. Tech Co., Ltd.	HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)	01/10/2019
K180180	M.I. Tech Co., Ltd.	HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)	11/02/2018
K190141	M.I.Tech Co., Ltd.	HANAROSTENT LowAx Colon/Rectum (NNN)	03/07/2019
K990034	MED INSTITUTE, INC.	WILSON-COOK COLONIC Z-STENT	04/17/2000