# Biliary Stent System For Benign Strictures
> **Product code: PNB** · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5011
## Classification
- **FDA Product Code:** PNB
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 876.5011
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

A benign stricture biliary stent system is a prescription device intended for treatment of benign biliary strictures. Stents are intended to be left indwelling for a limited amount of time and subsequently removed. The device consists of a metal stent and a delivery system intended to place the stent in the biliary ducts.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PNB)
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