# K113551: Esophageal TTS Stent

- Pathway: 510(k) (Traditional)
- Applicant: Taewoong Medical Co., Ltd.
- Decided: Feb 14, 2012 after 75 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: 8 generations back to K923119 (1992). 29 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080782: Niti-S Esophageal Stent, Taewoong Medical Co., Ltd. (2009) Summary page 1.
- K073667: Niti-S Biliary Stent, Taewoong Medical Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K211960: Agile Esophageal OTW Stent System (2021), 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
For use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

Source page: https://510kreport.com/device/K113551
Methodology: https://510kreport.com/methodology