# K223626: Niti-S Biliary Speed D Stent

- Pathway: 510(k) (Traditional)
- Applicant: Taewoong Medical Co., Ltd.
- Decided: May 26, 2023 after 172 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.
No later device cites it as a predicate yet.
0 of 25 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 5.

## Indications for use
The Niti-S Biliary Speed D Stent is indicated for the palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K223626
Methodology: https://510kreport.com/methodology