FDA Product Code MQR: Stent, Colonic, Metallic, Expandable
Leading manufacturers include Boston Scientific Corp, Boston Scientific Corporation and M.I. Tech Co., Ltd..
16
Total
16
Cleared
154d
Avg days
1996
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Stent, Colonic, Metallic, Expandable Devices (Product Code MQR)
16 devices
Cleared
Mar 08, 2024
WallFlex Colonic Stent System with Anchor Lock Delivery System
Boston Scientific Corporation
Gastroenterology & Urology
78d
Cleared
Aug 17, 2020
WallFlex Colonic Stent System with Anchor Lock Delivery System
Boston Scientific Corporation
Gastroenterology & Urology
109d
Cleared
Apr 17, 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
Boston Scientific Corporation
Gastroenterology & Urology
74d
Cleared
Mar 07, 2019
HANAROSTENT LowAx Colon/Rectum (NNN)
M.I. Tech Co., Ltd.
Gastroenterology & Urology
37d
Cleared
Jan 10, 2019
HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
M.I. Tech Co., Ltd.
Gastroenterology & Urology
15d
Cleared
Nov 02, 2018
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
M.I. Tech Co., Ltd.
Gastroenterology & Urology
283d
Cleared
Sep 15, 2006
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
Boston Scientific Corp
Gastroenterology & Urology
74d
Cleared
May 12, 2006
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
Boston Scientific Corporation
Gastroenterology & Urology
92d
Cleared
Sep 30, 2004
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
Boston Scientific Corp
Gastroenterology & Urology
59d
Cleared
Jul 14, 2003
ULTRAFLEX PRECISION COLONIC STENT
Boston Scientific Corp
Gastroenterology & Urology
125d
Cleared
May 12, 2000
WALLSTENT ENTERNAL PROSTHESIS
Boston Scientific Corp
Gastroenterology & Urology
102d
Cleared
Mar 16, 2000
MEMOTHERM COLORECTAL STENT
C.R. Bard, Inc.
Gastroenterology & Urology
393d
Cleared
Jun 22, 1999
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
Boston Scientific Corp
Gastroenterology & Urology
84d
About Product Code MQR - Regulatory Context
510(k) Submission Activity
16 total 510(k) submissions under product code MQR since 1996, with 16 receiving FDA clearance (average review time: 154 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.