# K964119: Wallstent Transhepatic Biliary Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Apr 28, 1997 after 195 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911292 (1991). 4 ancestors in all.
54 later devices descend from it; 8 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911292: Schneider Wallstent (R), Pfizer Hospital Products Group, Inc. (1991) Summary page 1.
- K914277: Wallstent (R) Trans Biliary Endo W/Unistep Deliv SY, Schneider U.S. Stent Div. (1991). Our OCR of the scanned summary read K914227, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “WALLSTENT® Biliary Endoscopic Endoprosthesis”.
- K923993: Wallstent Biliary Endoprotheses, Schneider U.S. Stent Div. (1994) Summary page 1.
- K961262: Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary Endoprosthesis, Boston Scientific Scimed, Inc. (1996) Summary page 1.

## Most influential descendants
- K982184: Wallstent Endoprosthesis (1998), 40 descendants of its own
- K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive (2001), 37 descendants of its own
- K073667: Niti-S Biliary Stent (2008), 23 descendants of its own
- K993232: Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System (1999), 14 descendants of its own
- K030107: 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM (2003), 11 descendants of its own

## Recalls of this device
- Dec 20, 2006 · Not classified · Z-0607-2007: Guidewire restriction during use (excessive adhesive in the guidewire lumen)
- Dec 20, 2006 · Not classified · Z-0609-2007: Guidewire restriction during use (excessive adhesive in the guidewire lumen)
- Dec 20, 2006 · Not classified · Z-0605-2007: Guidewire restriction during use (excessive adhesive in the guidewire lumen)
- Dec 20, 2006 · Not classified · Z-0606-2007: Guidewire restriction during use (excessive adhesive in the guidewire lumen)
- Dec 20, 2006 · Not classified · Z-0608-2007: Guidewire restriction during use (excessive adhesive in the guidewire lumen)
- Dec 20, 2006 · Not classified · Z-0604-2007: Guidewire restriction during use (excessive adhesive in the guidewire lumen)

## Indications for use
The WALLSTENT® Biliary Endoprosthesis is intended for use in the treatment of biliary strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K964119
Methodology: https://510kreport.com/methodology