# K060557: Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060

- Pathway: 510(k) (Traditional)
- Applicant: Idev Technologies, Inc.
- Decided: Aug 15, 2006 after 166 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: 5 generations back to K010445 (2001). 11 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051379: Protege RX GPS Self-Expanding Nitrinol Stent, Ev3 Corporation (2005)
- K032457: Modification to Smart Control Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2003) Summary page 1.

## Most influential descendants
- K071646: Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model # S-04-040-120 (2008), 5 descendants of its own
- K093893: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (2010), 4 descendants of its own
- K111766: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary Systems (2011), 2 descendants of its own
- 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

## Indications for use
The SureSave Self-Expandable Biliary Nitinol Stent and Precision Stent Delivery Catheter is intended for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K060557
Methodology: https://510kreport.com/methodology