# K083374: Wallflex Biliary RX Partially-Covered Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 22, 2009 after 160 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: 9 generations back to K923119 (1992). 21 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive, Boston Scientific Corp (2001) Summary page 1.
- K030107: 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM, Boston Scientific Corp (2003) Summary page 1.
- K061231: Wellflex  Biliary RX Stent System, Boston Scientific Corp (2006) Summary page 1.

## Most influential descendants
- K112543: Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic Covered Stent System (2011), 5 descendants of its own
- K122072: Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered) Wallflextm Biliary Transhepatic Ste (2012), 4 descendants of its own
- 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

## Indications for use
WallFlex® Biliary RX Partially Covered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K083374
Methodology: https://510kreport.com/methodology