# K072094: Choostent

- Pathway: 510(k) (Traditional)
- Applicant: M.I.Tech Co., Ltd.
- Decided: Sep 25, 2008 after 423 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: 3 generations back to K925406 (1995). 5 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012883: Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System, Boston Scientific Corp (2001) Summary page 2.

## Most influential descendants
- K092144: Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare, Models Befg and Befr (2010), 2 descendants of its own
- K140472: Bonastent Tracheal / Bronchial (2014), 1 descendant of its own
- K201342: HANAROSTENT Trachea/Bronchium (CCC) (2020), 0 descendants of its own
- K182910: Segmented Esophageal Stent System (2019), 0 descendants of its own
- K093537: Hanarostent Esophagus (CCC) (2010), 0 descendants of its own

## Indications for use
The CHOOSTENTTM covered esophageal stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and or extrinsic malignant tumors only and occlusion of concurrent esophageal fistula.

Source page: https://510kreport.com/device/K072094
Methodology: https://510kreport.com/methodology