# K243619: Niti-S Esophageal Stent; Esophageal TTS Stent

- Pathway: 510(k) (Traditional)
- Applicant: Taewoong Medical Co., Ltd.
- Decided: Oct 30, 2025 after 342 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: 13 generations back to K923119 (1992). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240522: Esophageal TTS Stent, Taewoong Medical (2024) Summary page 5.
- K080782: Niti-S Esophageal Stent, Taewoong Medical Co., Ltd. (2009) Summary page 5.

## Indications for use
The Niti-S Esophageal Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas. 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/K243619
Methodology: https://510kreport.com/methodology