FDA.report

510(k) K234046

Device
WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock
Applicant
Boston Scientific Corporation
510(k) number
K234046
Product code
MQR
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-08
Date received
2023-12-21
Regulation
878.3610
Classification name
Stent, Colonic, Metallic, Expandable
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Tijana Prodanovic
Address
300 Boston Scientific Way Marborough MA US 01752 01752

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MQR

510(k)DeviceApplicantDecision date
K201159WallFlex Colonic Stent System with Anchor Lock Delivery SystemBoston Scientific Corporation2020-08-17
K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery SystemBoston Scientific Corporation2020-04-17
K190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd.2019-03-07
K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.2019-01-10
K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.2018-11-02
K113510EVOLUTION COLONIC STENT SYSTEMCook Ireland, Ltd.2012-05-17
K061877WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEMBoston Scientific Corp2006-09-15
K060323ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380Boston Scientific Corporation2006-05-12
K042065WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEMBoston Scientific Corp2004-09-30
K030769ULTRAFLEX PRECISION COLONIC STENTBoston Scientific Corp2003-07-14
K000281WALLSTENT ENTERNAL PROSTHESISBoston Scientific Corp2000-05-12
K990034WILSON-COOK COLONIC Z-STENTMed Institute, Inc.2000-04-17
K990504MEMOTHERM COLORECTAL STENTC.R. Bard, Inc.2000-03-16
K991056WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEMBoston Scientific Corp1999-06-22
K954290WALLSTENT ENTERAL ENDOPROTHESISBoston Scientific Scimed, Inc.1996-07-10