# K073667: Niti-S Biliary Stent

- Pathway: 510(k) (Abbreviated)
- Applicant: Taewoong Medical Co., Ltd.
- Decided: Nov 19, 2008 after 329 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). 23 ancestors in all.
23 later devices descend from it; 6 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040930: Zilver Biliary Stent System Usw, Wilson-Cook Medical, Inc. (2004) Summary page 1.
- K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive, Boston Scientific Corp (2001) Summary page 1.
- K041648: Niti-S Stent & Introducer, Model Eoxxxx, Taewoong Medical Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K113551: Esophageal TTS Stent (2012), 10 descendants of its own
- K123205: Esophageal TTS Stent (2013), 9 descendants of its own
- K111149: Hanarostent Biliary (NNN) (2011), 6 descendants of its own
- K211706: Esophageal TTS Stent (2021), 3 descendants of its own
- K180144: Agile Esophageal Stent System (2018), 3 descendants of its own

## Indications for use
Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K073667
Methodology: https://510kreport.com/methodology