PNB
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Biliary Stent System For Benign Strictures
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5011
- Medical specialty
- Gastroenterology, Urology
- Flags
- Implant
- FDA 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.
- Adverse events (MAUDE)
- 2021: 29 · 2022: 16 · 2023: 27 · 2024: 39 · 2025: 37 · 2026: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WallFlex Biliary RX Fully Covered Stent System RMV (DEN150040) | Boston Scientific | 2016-06-03 |
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Every clearance here is in the API, with alerts when new ones post.