# K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 15, 2001 after 91 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: 6 generations back to K923119 (1992). 16 ancestors in all.
37 later devices descend from it; 7 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000308: Wallstent Biliary Endoprosthesis, Boston Scientific Corp (2000) Summary page 1.
- K982184: Wallstent Endoprosthesis, Boston Scientific Scimed, Inc. (1998) Summary page 1.
- K964119: Wallstent Transhepatic Biliary Endoprosthesis, Boston Scientific Scimed, Inc. (1997) Summary page 1.
- K961262: Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis, Boston Scientific Scimed, Inc. (1996) Summary page 1.

## Most influential descendants
- K073667: Niti-S Biliary Stent (2008), 23 descendants of its own
- K030107: 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM (2003), 11 descendants of its own
- K113551: Esophageal TTS Stent (2012), 10 descendants of its own
- K061231: Wellflex  Biliary RX Stent System (2006), 10 descendants of its own
- K123205: Esophageal TTS Stent (2013), 9 descendants of its own

## Recalls of this device
- Jan 28, 2004 · Not classified · Z-0563-04: Incorrect label states stent covered with 'Permalume Covering', product is uncovered

## Indications for use
The Wallstent™ RX Biliary Endoprosthesis is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K012752
Methodology: https://510kreport.com/methodology