Cleared Traditional

AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System

K181905 · Boston Scientific Corporation · Gastroenterology & Urology

Mar 2019

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K181905 is an FDA 510(k) clearance for the AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System, a Pancreatic Stent, Covered, Metallic, Removable (Class II — Special Controls, product code PCU), submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on March 25, 2019, 252 days after receiving the submission on July 16, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5015.

Submission Details

510(k) Number	K181905 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2018
Decision Date	March 25, 2019
Days to Decision	252 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	PCU — Pancreatic Stent, Covered, Metallic, Removable
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5015
Definition	To Facilitate Transmural Endoscopic Drainage Of Pancreatic Pseudocysts