# K041648: Niti-S Stent & Introducer, Model Eoxxxx

- Pathway: 510(k) (Traditional)
- Applicant: Taewoong Medical Co., Ltd.
- Decided: Apr 28, 2005 after 315 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955347 (1996). 2 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032930: Ultraflex Esophageal NG Stent System, Boston Scientific Corp (2003) Summary page 1.

## Most influential descendants
- K073667: Niti-S Biliary Stent (2008), 23 descendants of its own
- K080782: Niti-S Esophageal Stent (2009), 15 descendants of its own
- 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

## Indications for use
Niti-S Esophageal Non-covered Stent & Introducer is intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors.

Source page: https://510kreport.com/device/K041648
Methodology: https://510kreport.com/methodology