# K122072: Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered) Wallflextm Biliary Transhepatic Ste

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Sep 28, 2012 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: 11 generations back to K923119 (1992). 25 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061231: Wellflex  Biliary RX Stent System, Boston Scientific Corp (2006) Summary page 1.
- K081733: 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890, Boston Scientific Corp (2008) Summary page 1.
- K083374: Wallflex Biliary RX Partially-Covered Stent System, Boston Scientific Corp (2009) Summary page 1.
- K083627: Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520, M00570530, M00570540, Boston Scientific Corporation (2009) Summary page 1.
- K112543: Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic Covered Stent System, Boston Scientific Corporation (2011) Summary page 2.

## Most influential descendants
- K140630: Wallflex Biliary RX Stent System (2014), 3 descendants of its own
- 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

## Indications for use
For use in the palliative treatment of biliary strictures produced by malignant neoplasms

Source page: https://510kreport.com/device/K122072
Methodology: https://510kreport.com/methodology