FDA Product Code PCU: Pancreatic Stent, Covered, Metallic, Removable
To Facilitate Transmural Endoscopic Drainage Of Pancreatic Pseudocysts
Leading manufacturers include Boston Scientific Corporation, Xlumena, Inc. and Boston Scientific Corp.
11
Total
10
Cleared
141d
Avg days
2013
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
204d
recently vs 135d historically
FDA 510(k) Cleared Pancreatic Stent, Covered, Metallic, Removable Devices (Product Code PCU)
11 devices
Cleared
Mar 13, 2026
Niti-S SPAXUS Stent
Taewoong Medical Co., Ltd.
Gastroenterology & Urology
204d
Cleared
Sep 07, 2022
AXIOS Stent and Electrocautery-Enhanced Delivery System
Boston Scientific Corporation
Gastroenterology & Urology
237d
Cleared
Apr 15, 2021
AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation
Gastroenterology & Urology
178d
Cleared
Aug 26, 2019
AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation
Gastroenterology & Urology
26d
Cleared
Mar 25, 2019
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation
Gastroenterology & Urology
252d
Cleared
Feb 18, 2017
AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation
Gastroenterology & Urology
89d
Cleared
Dec 11, 2015
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
Boston Scientific Corporation
Gastroenterology & Urology
46d
Cleared
Oct 06, 2015
AXIOS Stent and Delivery System
Boston Scientific Corporation
Gastroenterology & Urology
27d
Cleared
Aug 05, 2015
AXIOS Stent with Electrocautery Enhanced Delivery System
Boston Scientific Corp
Gastroenterology & Urology
140d
Cleared
Apr 23, 2014
AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
Xlumena, Inc.
Gastroenterology & Urology
49d
Not Cleared
Dec 18, 2013
AXIOS STENT AND DELIVERY SYSTEM
Xlumena, Inc.
Gastroenterology & Urology
302d
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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PCU Product Code
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 →