FDA Product Code MUM: Stent, Metallic, Expandable, Duodenal
Leading manufacturers include Taewoong Medical Co., Ltd., Boston Scientific Corp and Boston Scientific Scimed, Inc..
6
Total
6
Cleared
149d
Avg days
1998
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
26d
recently vs 173d historically
FDA 510(k) Cleared Stent, Metallic, Expandable, Duodenal Devices (Product Code MUM)
6 devices
Cleared
Mar 31, 2025
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
Taewoong Medical Co., Ltd.
Gastroenterology & Urology
26d
Cleared
Jun 14, 2023
Niti-S Duodenal Stent
Taewoong Medical Co., Ltd.
Gastroenterology & Urology
264d
Cleared
Dec 04, 2006
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
Boston Scientific Corp
Gastroenterology & Urology
81d
Cleared
Apr 03, 1998
WALLSTENT ENTERAL ENDOPROSTHESIS
Boston Scientific Scimed, Inc.
Gastroenterology & Urology
80d
About Product Code MUM - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code MUM since 1998, with 6 receiving FDA clearance (average review time: 149 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - MUM Product Code
Recent submissions under MUM have taken an average of 26 days to reach a decision - down from 173 days historically, suggesting improved FDA processing for this classification.
MUM devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →