# K111766: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary Systems

- Pathway: 510(k) (Traditional)
- Applicant: Idev Technologies, Inc.
- Decided: Oct 19, 2011 after 118 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010445 (2001). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093893: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, Idev Technologies, Inc. (2010) Summary page 1.
- K063532: Bard E Luminexx Biliary Stent, Bard Peripheral Vascular, Inc. (2008) Summary page 1.
- K062798: Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB, Cordis Corp. (2008) Summary page 1.

## Most influential descendants
- K122546: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (2012), 1 descendant of its own
- K130591: Supera Veritas (2013), 0 descendants of its own

## Recalls of this device
- May 29, 2012 · Class II · Z-1550-2013: There was an error on the outer labeling of this device. The inner label was correct.

## Indications for use
The SUPERA™ VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K111766
Methodology: https://510kreport.com/methodology