# K201160: HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)

- Pathway: 510(k) (Traditional)
- Applicant: M.I.Tech Co., Ltd.
- Decided: Jul 23, 2021 after 449 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: 6 generations back to K925406 (1995). 18 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172813: Esophageal Stent System, Micro-Tech (Nanjing) Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- K253327: HANAROSTENT Esophagus Upper (CCC) (2025), 0 descendants of its own
- K213251: HANAROSTENT Esophagus Asymmetric (CCC) (2021), 0 descendants of its own

## Indications for use
The HANAROSTENT® Esophagus (CCC) and the HANAROSTENT® Esophagus (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/K201160
Methodology: https://510kreport.com/methodology