Product code PNB— Gastroenterology, Urology
WallFlex Biliary RX Fully Covered Stent System RMV
- Classification name
- Biliary Stent System For Benign Strictures
- Device class
- Class 2
- Regulation
- 21 CFR 876.5011
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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 context for product code PNB
FDA has cleared device under product code PNB, all in 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code PNB
Adverse events under product code PNB
product code PNB- Death
- 4
- Injury
- 132
- Total
- 136
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code PNB
Data sourced from openFDA. This site is unofficial and independent of the FDA.