# K183396: HANAROSTENT FASTTM Biliary (NNN)

- Pathway: 510(k) (Traditional)
- Applicant: M.I.Tech Co., Ltd.
- Decided: Feb 11, 2019 after 66 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.
No later device cites it as a predicate yet.
0 of 26 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 6.

## Indications for use
The HANAROSTENT® FAST™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K183396
Methodology: https://510kreport.com/methodology