# K092144: Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare, Models Befg and Befr

- Pathway: 510(k) (Traditional)
- Applicant: Endochoice, Inc.
- Decided: Feb 22, 2010 after 222 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: 5 generations back to K925406 (1995). 23 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 26 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 1.
- K073266: Wallflex Partially Covered Esophageal Stent System, Boston Scientific Corp (2008) Summary page 1.
- K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730, Boston Scientific Corporation (2009) Summary page 1.
- K072094: Choostent, M.I.Tech Co., Ltd. (2008) Summary page 1.
- K080782: Niti-S Esophageal Stent, Taewoong Medical Co., Ltd. (2009) Summary page 1.
- K041648: Niti-S Stent & Introducer, Model Eoxxxx, Taewoong Medical Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K140472: Bonastent Tracheal / Bronchial (2014), 1 descendant of its own
- K201342: HANAROSTENT Trachea/Bronchium (CCC) (2020), 0 descendants of its own

## Indications for use
The BONASTENT™ Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistula.

Source page: https://510kreport.com/device/K092144
Methodology: https://510kreport.com/methodology