510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QGEClass I

Biliary Stent, Drain, And Dilator Accessories

21 CFR 876.5012 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QGE is the FDA product code for Biliary Stent, Drain, And Dilator Accessories, a class I device type, regulated under 21 CFR 876.5012. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QGE
Device name
Biliary Stent, Drain, And Dilator Accessories
FDA 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.
Regulation
21 CFR 876.5012
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code