ClearanceBrief
Panels › General, Plastic Surgery › Product code MQR · Class 2

Stent, Colonic, Metallic, Expandable

Regulation 878.3610

0510(k)s in 12 months (16 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in MQR

Decided510(k)Device and applicantCode
Mar 8, 2024K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery
Boston Scientific Corporation
MQR
Aug 17, 2020K201159WallFlex Colonic Stent System with Anchor Lock Delivery System
Boston Scientific Corporation
MQR
Apr 17, 2020K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Loc
Boston Scientific Corporation
MQR
Mar 7, 2019K190141HANAROSTENT LowAx Colon/Rectum (NNN)
M.I.Tech Co., Ltd., KR
MQR
Jan 10, 2019K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
M.I.Tech Co., Ltd., KR
MQR
Nov 2, 2018K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
M.I.Tech Co., Ltd., KR
MQR
May 17, 2012K113510EVOLUTION COLONIC STENT SYSTEM
Cook Ireland, Ltd., IE
MQR
Sep 15, 2006K061877WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
Boston Scientific Corp
MQR
May 12, 2006K060323ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
Boston Scientific Corporation
MQR
Sep 30, 2004K042065WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
Boston Scientific Corp
MQR
Jul 14, 2003K030769ULTRAFLEX PRECISION COLONIC STENT
Boston Scientific Corp
MQR
May 12, 2000K000281WALLSTENT ENTERNAL PROSTHESIS
Boston Scientific Corp
MQR
Apr 17, 2000K990034WILSON-COOK COLONIC Z-STENT
Med Institute, Inc.
MQR
Mar 16, 2000K990504MEMOTHERM COLORECTAL STENT
C.R. Bard, Inc.
MQR
Jun 22, 1999K991056WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
Boston Scientific Corp
MQR
Jul 10, 1996K954290WALLSTENT ENTERAL ENDOPROTHESIS
Boston Scientific Scimed, Inc.
MQR

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