# K223469: WallFlex™ Biliary RX Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jun 15, 2023 after 210 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). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 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.

## 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 obstructions prior to surgery.

Source page: https://510kreport.com/device/K223469
Methodology: https://510kreport.com/methodology