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MQR — Stent, Colonic, Metallic, Expandable Class II

FDA Device Classification

Classification Details

Product Code
MQR
Device Class
Class II
Regulation Number
878.3610
Submission Type
Review Panel
GU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K234046boston scientific corporationWallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex DuodenaMarch 8, 2024
K201159boston scientific corporationWallFlex Colonic Stent System with Anchor Lock Delivery SystemAugust 17, 2020
K200257boston scientific corporationWallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex DuApril 17, 2020
K190141m.i. tech coHANAROSTENT LowAx Colon/Rectum (NNN)March 7, 2019
K183616m.i. tech coHANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)January 10, 2019
K180180m.i. tech coHANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNNovember 2, 2018
K113510cook irelandEVOLUTION COLONIC STENT SYSTEMMay 17, 2012
K061877boston scientificWALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEMSeptember 15, 2006
K060323boston scientific corporationULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380May 12, 2006
K042065boston scientificWALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEMSeptember 30, 2004
K030769boston scientificULTRAFLEX PRECISION COLONIC STENTJuly 14, 2003
K000281boston scientificWALLSTENT ENTERNAL PROSTHESISMay 12, 2000
K990034med instituteWILSON-COOK COLONIC Z-STENTApril 17, 2000
K990504c.r. bardMEMOTHERM COLORECTAL STENTMarch 16, 2000
K991056boston scientificWALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEMJune 22, 1999
K954290boston scientific scimedWALLSTENT ENTERAL ENDOPROTHESISJuly 10, 1996