# K140630: Wallflex Biliary RX Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: May 23, 2014 after 73 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K923119 (1992). 30 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122072: Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered) Wallflextm Biliary Transhepatic Ste, Boston Scientific Corporation (2012) Summary page 1.
- K101314: Advanix Biliary Stent with Naviflex RX Delivery System, Boston Scientific Corp (2010) Summary page 1.

## 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
- K223469: WallFlex™ Biliary RX Stent System (2023), 1 descendant of its own
- K242950: WallFlex Biliary PLUS RX Stent System (2024), 0 descendants of its own

## Recalls of this device
- Aug 7, 2020 · Class II · Z-2958-2020: Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device

## Indications for use
The WailFlexTm Biliary RX Stents are 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/K140630
Methodology: https://510kreport.com/methodology