Cleared Traditional

AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System

K153088 · Boston Scientific Corporation · Gastroenterology & Urology

Dec 2015

Decision

46d

Days

Class 2

Risk

About This 510(k) Submission

K153088 is an FDA 510(k) clearance for the AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery 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 December 11, 2015, 46 days after receiving the submission on October 26, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5015.

Submission Details

510(k) Number	K153088 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 26, 2015
Decision Date	December 11, 2015
Days to Decision	46 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