# K240464: WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Aug 30, 2024 after 196 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: 13 generations back to K923119 (1992). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140630: Wallflex Biliary RX Stent System, Boston Scientific (2014) Summary page 5.
- DEN150040: WallFlex Biliary RX Fully Covered Stent System RMV, Boston Scientific (2016) Summary page 5.
- K171809: Epic Biliary Endoscopic Stent System, Boston Scientific Corporation (2017) Summary page 5.

## Most influential descendants
- K242950: WallFlex Biliary PLUS RX Stent System (2024), 0 descendants of its own

## Indications for use
The WallFlex Biliary 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. The WallFlex Biliary RX Fully Covered Stent System RMV is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. The Epic Biliary Endoscopic Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K240464
Methodology: https://510kreport.com/methodology