# K200860: HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

- Pathway: 510(k) (Traditional)
- Applicant: M.I.Tech Co., Ltd.
- Decided: May 20, 2020 after 49 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: 10 generations back to K923119 (1992). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123205: Esophageal TTS Stent, Taewoong Medical Co., Ltd. (2013) Summary page 5.

## Indications for use
The HANAROSTENT® Esophagus TTS (CCC) and HANAROSTENT® Esophagus TTS (NCN) are intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

Source page: https://510kreport.com/device/K200860
Methodology: https://510kreport.com/methodology