# Biliary Stent, Drain, And Dilator Accessories
> **Product code: QGE** · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5012
## Classification
- **FDA Product Code:** QGE
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 876.5012
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QGE)
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