# K253327: HANAROSTENT Esophagus Upper (CCC)

- Pathway: 510(k) (Special)
- Applicant: M.I.Tech Co., Ltd.
- Decided: Oct 30, 2025 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: 7 generations back to K925406 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201160: HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN), M.I.Tech Co., Ltd. (2021) Summary page 6.

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

Source page: https://510kreport.com/device/K253327
Methodology: https://510kreport.com/methodology