ClearanceBrief
Panels › Gastroenterology, Urology › Product code PCU · Class 2

Pancreatic Stent, Covered, Metallic, Removable

Regulation 876.5015

1510(k)s in 12 months (11 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Get daily alerts for PCUSample briefCSV

Top companies in PCU

Company510(k)sRecalls
Boston Scientific Corp86
Xlumena, Inc.20
Taewoong Medical Co., Ltd.10
Decided510(k)Device and applicantCode
Mar 13, 2026K252648Niti-S SPAXUS Stent
Taewoong Medical Co., Ltd., KR
PCU
Sep 7, 2022K220112AXIOS Stent and Electrocautery-Enhanced Delivery System
Boston Scientific Corporation
PCU
Apr 15, 2021K203132AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation
PCU
Aug 26, 2019K192043AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation
PCU
Mar 25, 2019K181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation
PCU
Feb 18, 2017K163272AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation
PCU
Dec 11, 2015K153088AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
Boston Scientific Corporation
PCU
Oct 6, 2015K152572AXIOS Stent and Delivery System
Boston Scientific Corporation
PCU
Aug 5, 2015K150692AXIOS Stent with Electrocautery Enhanced Delivery System
Boston Scientific Corp
PCU
Apr 23, 2014K140561AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
Xlumena, Inc.
PCU
Dec 18, 2013DEN130007AXIOS STENT AND DELIVERY SYSTEM
Xlumena, Inc.
PCU

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