# K080782: Niti-S Esophageal Stent

- Pathway: 510(k) (Abbreviated)
- Applicant: Taewoong Medical Co., Ltd.
- Decided: Jan 30, 2009 after 317 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- 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: 3 generations back to K955347 (1996). 7 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940838: Microvasive Ultraflex Esophageal Stent System, Boston Scientific Corp (1994) Summary page 1.
- K041648: Niti-S Stent & Introducer, Model Eoxxxx, Taewoong Medical Co., Ltd. (2005) Summary page 1.
- K011591: Esophageal Z-Stent with Dua Anti-Reflux Valve, Wilson-Cook Medical, Inc. (2002) 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
- K211706: Esophageal TTS Stent (2021), 3 descendants of its own
- K180144: Agile Esophageal Stent System (2018), 3 descendants of its own
- K221482: Esophageal TTS Stent (2022), 2 descendants of its own

## Recalls of this device
- Oct 18, 2019 · Class II · Z-1229-2020: Misprinted IFUs shipped with esophageal stents

## Indications for use
Niti-S Esophageal Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

Source page: https://510kreport.com/device/K080782
Methodology: https://510kreport.com/methodology