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510(k) K180180

Device
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
Applicant
M.I. Tech Co., Ltd.
510(k) number
K180180
Product code
MQR  
Decision
Substantially Equivalent (SESE)
Decision date
2018-11-02
Date received
2018-01-23
Regulation
878.3610
Classification name
Stent, Colonic, Metallic, Expandable
Medical specialty
General & Plastic Surgery
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Inae Kim
Address
174 Habuk 2-Gil, Jinwi-Myeon Pyeongtaek-Si KR 17706 17706

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K234046WallFlex 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 Delivery SystemBoston Scientific Corporation2024-03-08
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
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

Legacy Summary#

summary

FDA Review#

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