# K012216: Niroyal Biliary Premounted Stent System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Aug 17, 2001 after 32 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: 1 generation back to K003929 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003929: Niroyal Biliary Premounted Stent System, Boston Scientific Corp (2001) Summary page 1.

## Indications for use
The NIROYAL® Biliary Premounted Stent System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K012216
Methodology: https://510kreport.com/methodology