Home / Device Classification / QGE

QGE — Biliary Stent, Drain, And Dilator Accessories Class I

FDA Device Classification

FDA product code QGE covers "Biliary Stent, Drain, And Dilator Accessories", a Class I medical device regulated under 21 CFR 876.5012. Submissions are reviewed by the Gastroenterology, Urology panel.

Classification Details

Product Code
QGE
Device Class
Class I
Regulation Number
876.5012
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

Biliary stent, drain, and dilator accessories are manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube.

FDA data resources