# K203162: Advanix Biliary Stent with NaviFlex RX Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Dec 18, 2020 after 56 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: 3 generations back to K834468 (1984). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101314: Advanix Biliary Stent with Naviflex RX Delivery System, Boston Scientific Corp (2010) Summary page 4.

## Most influential descendants
- K260835: ARCHIMEDES Biodegradable Stent (Medium) (2026), 0 descendants of its own

## Indications for use
Advanix™ Biliary Stent with NaviFlex™ RX Delivery System 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/K203162
Methodology: https://510kreport.com/methodology