# K081956: Medinol X-Suit Nir Biliary Metallic Stent

- Pathway: 510(k) (Traditional)
- Applicant: Medinol, Ltd.
- Decided: Jan 9, 2009 after 184 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: 7 generations back to K923119 (1992). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010242: Cook Zilver Biliary Stent, Cook, Inc. (2001) Summary page 1.
- K020788: Wilson-Cook  Zilver Biliary Stent, Wilson-Cook Medical, Inc. (2002) Summary page 1.
- K031186: Luminexx Endoscopic Biliary Stent, C.R. Bard, Inc. (2003) Summary page 1.
- K925406: Biliary Endoprostheses W/Unistep Delivery System, Schneider Intl., Ltd. (1995) 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.
- K000308: Wallstent Biliary Endoprosthesis, Boston Scientific Corp (2000) Summary page 1.
- K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive, Boston Scientific Corp (2001) Summary page 1.

## Indications for use
X-Suit NIR® Biliary Metallic Stent is indicated for the palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K081956
Methodology: https://510kreport.com/methodology