# K101786: Advanix Double Pigtail Biliary Stent

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jul 23, 2010 after 28 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: 2 generations back to K834468 (1984). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965147: Biliary Stent, Biliary Stent System, Biliary Endoprosthesis, Boston Scientific Corp (1997) Summary page 1.
- K834468: Drainage Stent, Microvasive (1984) Summary page 1.

## Most influential descendants
- K181669: ConvertX Biliary Stent System (2019), 0 descendants of its own

## Indications for use
AdvanixTm Double Pigtail Biliary Stent is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

Source page: https://510kreport.com/device/K101786
Methodology: https://510kreport.com/methodology