# K221482: Esophageal TTS Stent

- Pathway: 510(k) (Special)
- Applicant: Taewoong Medical Co., Ltd.
- Decided: Jun 22, 2022 after 30 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: 11 generations back to K923119 (1992). 32 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211706: Esophageal TTS Stent, Taewoong Medical Co., Ltd. (2021) Summary page 4.
- K123205: Esophageal TTS Stent, Taewoong Medical Co., Ltd. (2013) Summary page 4.
- K113551: Esophageal TTS Stent, Taewoong Medical Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K240522: Esophageal TTS Stent (2024), 1 descendant of its own
- K243619: Niti-S Esophageal Stent; Esophageal TTS Stent (2025), 0 descendants of its own

## Indications for use
The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.

Source page: https://510kreport.com/device/K221482
Methodology: https://510kreport.com/methodology