QXH · Class II · 21 CFR 876.5016

FDA Product Code QXH: Gallbladder Drainage Stent And Delivery System

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.

Leading manufacturers include Boston Scientific Corporation.

1
Total
0
Cleared
144d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Gallbladder Drainage Stent And Delivery System Devices (Product Code QXH)

1 devices
1–1 of 1
Not Cleared Aug 18, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent)
DEN230019
Boston Scientific Corporation
Gastroenterology & Urology · 144d

About Product Code QXH - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QXH since 2023, with 0 receiving FDA clearance (average review time: 144 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QXH devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →