# K242950: WallFlex Biliary PLUS RX Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Dec 6, 2024 after 74 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K923119 (1992). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223469: WallFlex™ Biliary RX Stent System, Boston Scientific Corporation (2023) Summary page 5.
- K240464: WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV, Boston Scientific (2024) Summary page 5.

## Indications for use
The WallFlex Biliary PLUS RX Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.

Source page: https://510kreport.com/device/K242950
Methodology: https://510kreport.com/methodology