# K152853: WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 20, 2015 after 52 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.
No later device cites it as a predicate yet.
0 of 7 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 4.

## Indications for use
The WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary are indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K152853
Methodology: https://510kreport.com/methodology