FDA product code QXH

Gallbladder Drainage Stent And Delivery System

Gastroenterology, Urology·Class 2·21 CFR 876.5016·Implantable
US regulatory classifications
US Product Code (FDA)
QXH
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.5016
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

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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About this record

Gallbladder Drainage Stent And Delivery System is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.