FDA Product Code MUM: Stent, Metallic, Expandable, Duodenal
Leading manufacturers include Taewoong Medical Co., Ltd..
FDA 510(k) Cleared Stent, Metallic, Expandable, Duodenal Devices (Product Code MUM)
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 Review Time
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 →