# K093003: Bonastent Biliary

- Pathway: 510(k) (Traditional)
- Applicant: Endochoice, Inc.
- Decided: Mar 24, 2010 after 177 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K923119 (1992). 24 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073667: Niti-S Biliary Stent, Taewoong Medical Co., Ltd. (2008) Summary page 1.
- (no number) WallFlex Biliary RX Stent System: named in the summary without a submission number

## Most influential descendants
- K140472: Bonastent Tracheal / Bronchial (2014), 1 descendant of its own
- K201342: HANAROSTENT Trachea/Bronchium (CCC) (2020), 0 descendants of its own
- K140760: Bonastent Biliary (2014), 0 descendants of its own

## Indications for use
The BONASTENT® Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K093003
Methodology: https://510kreport.com/methodology