Product code QGE

Device name
Biliary Stent, Drain, And Dilator Accessories
Medical specialty
Gastroenterology, Urology
Device class
1
Regulation number
876.5012
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset