# K093537: Hanarostent Esophagus (CCC)

- Pathway: 510(k) (Special)
- Applicant: M.I.Tech Co., Ltd.
- Decided: Jun 4, 2010 after 200 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: 4 generations back to K925406 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072094: Choostent, M.I.Tech Co., Ltd. (2008) Summary page 2.
- K032930: Ultraflex Esophageal NG Stent System, Boston Scientific Corp (2003) Summary page 2.

## Indications for use
HANAROSTENT® Esophagus (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/K093537
Methodology: https://510kreport.com/methodology