# K223354: EGIS Biliary Single Bare Stent

- Pathway: 510(k) (Traditional)
- Applicant: S&G Biotech, Inc.
- Decided: Sep 21, 2023 after 323 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: 9 generations back to K923119 (1992). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111149: Hanarostent Biliary (NNN), M.I.Tech Co., Ltd. (2011) Summary page 5.

## Most influential descendants
- K242845: EGIS Biliary Double Bare Stent (BDB080405) (2025), 0 descendants of its own

## Indications for use
The EGIS Biliary Single Bare Stent is indicated for the palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K223354
Methodology: https://510kreport.com/methodology