# K982005: Wallstent Transhepatic Biliary Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Sep 2, 1998 after 86 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: 3 generations back to K911292 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K964119: Wallstent Transhepatic Biliary Endoprosthesis, Boston Scientific Scimed, Inc. (1997) Summary page 1.

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

Source page: https://510kreport.com/device/K982005
Methodology: https://510kreport.com/methodology