# DEN150040: WallFlex Biliary RX Fully Covered Stent System RMV

- Pathway: De Novo (Direct)
- Applicant: Boston Scientific
- Decided: Jun 3, 2016 after 280 days
- Product code: PNB (Biliary Stent System For Benign Strictures)
- Device class: 2
- Regulation: 21 CFR 876.5011
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K240464: WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV (2024), 1 descendant of its own
- K242950: WallFlex Biliary PLUS RX Stent System (2024), 0 descendants of its own

## Indications for use
indicated for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis.

Source page: https://510kreport.com/device/DEN150040
Methodology: https://510kreport.com/methodology