# K240522: Esophageal TTS Stent

- Pathway: 510(k) (Special)
- Applicant: Taewoong Medical
- Decided: Mar 22, 2024 after 28 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: 12 generations back to K923119 (1992). 33 ancestors in all.
1 later device descends 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)
- K221482: Esophageal TTS Stent, Taewoong Medical Co., Ltd. (2022) Summary page 5.

## Most influential descendants
- 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/K240522
Methodology: https://510kreport.com/methodology