FDA Product Code PCU: Pancreatic Stent, Covered, Metallic, Removable
To Facilitate Transmural Endoscopic Drainage Of Pancreatic Pseudocysts
Leading manufacturers include Boston Scientific Corporation and Taewoong Medical Co., Ltd..
FDA 510(k) Cleared Pancreatic Stent, Covered, Metallic, Removable Devices (Product Code PCU)
About Product Code PCU - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code PCU since 2013, with 10 receiving FDA clearance (average review time: 141 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 PCU have taken an average of 204 days to reach a decision - up from 135 days historically. Manufacturers should account for longer review timelines in current project planning.
PCU devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →