# K993232: Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Dec 30, 1999 after 94 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.
14 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K061231: Wellflex  Biliary RX Stent System (2006), 10 descendants of its own
- K081733: 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890 (2008), 7 descendants of its own
- K083374: Wallflex Biliary RX Partially-Covered Stent System (2009), 6 descendants of its own
- K083627: Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520, M00570530, M00570540 (2009), 6 descendants of its own
- K112543: Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic Covered Stent System (2011), 5 descendants of its own

## Indications for use
The Wallstent® Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K993232
Methodology: https://510kreport.com/methodology