# K012822: Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model 71-XXX

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Oct 24, 2001 after 62 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: 4 generations back to K911292 (1991). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993232: Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System, Boston Scientific Scimed, Inc. (1999) Summary page 3.

## Most influential descendants
- K032137: Precise RX Nitinol Stent Transhepatic Biliary System (2003), 0 descendants of its own

## Indications for use
The Biliary Wallstent® Endoprosthesis with Monorail Delivery System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K012822
Methodology: https://510kreport.com/methodology