# K180868: Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland
- Decided: Jul 6, 2018 after 94 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: 1 generation back to K896323 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896323: Wilson-Cook Endoscopic Nasal Biliary Drainage Sets, Wilson-Cook Medical, Inc. (1990) Summary page 5.

## Indications for use
This device is used for temporary endoscopic drainage of the biliary duct through the nasal passage by use of an indwelling catheter.

Source page: https://510kreport.com/device/K180868
Methodology: https://510kreport.com/methodology