Atlas FDA

PCU

11 FDA 510(k) clearances · Product code

140 daysmedian time to decision
252 days90th percentile
11clearances measured

FDA profile

Official device name
Pancreatic Stent, Covered, Metallic, Removable
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5015
Medical specialty
Gastroenterology, Urology
Flags
Implant
FDA definition
To facilitate transmural endoscopic drainage of pancreatic pseudocysts
Adverse events (MAUDE)
2021: 162 · 2022: 208 · 2023: 260 · 2024: 416 · 2025: 301 · 2026: 205
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Niti-S SPAXUS Stent (K252648)Taewoong Medical Co., Ltd.2026-03-13
AXIOS Stent and Electrocautery-Enhanced Delivery System (K220112)Boston Scientific Corporation2022-09-07
AXIOS Stent and Electrocautery Enhanced Delivery System (K203132)Boston Scientific Corporation2021-04-15
AXIOS Stent and Electrocautery Enhanced Delivery System (K192043)Boston Scientific Corporation2019-08-26
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System (K181905)Boston Scientific Corporation2019-03-25
AXIOS Stent and Electrocautery Enhanced Delivery System (K163272)Boston Scientific Corporation2017-02-18
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System (K153088)Boston Scientific Corporation2015-12-11
AXIOS Stent and Delivery System (K152572)Boston Scientific Corporation2015-10-06
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) (K140561)Xlumena, Inc.2014-04-23
AXIOS STENT AND DELIVERY SYSTEM (DEN130007)Xlumena, Inc.2013-12-18

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Every clearance here is in the API, with alerts when new ones post.