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510(k) DEN230019

AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) by Boston Scientific Corporation — Product Code QXH

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 18, 2023
Date Received
March 27, 2023
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gallbladder Drainage Stent And Delivery System
Device Class
Class II
Regulation Number
876.5016
Review Panel
GU
Submission Type

A gallbladder drainage stent is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder. This device may also include a delivery system.

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