# K101314: Advanix Biliary Stent with Naviflex RX Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 23, 2010 after 73 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.
14 later devices descend from it; 4 cite it directly.
0 of 18 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.

## Most influential descendants
- K133700: Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and Pushers (2014), 4 descendants of its own
- K193600: EndoGI Biliary Stent System (2020), 3 descendants of its own
- K140630: Wallflex Biliary RX Stent System (2014), 3 descendants of its own
- K202477: EndoGI S-Path Biliary Stent System (2020), 2 descendants of its own
- K243412: ARCHIMEDES Biodegradable Pancreatic Stent (2025), 1 descendant of its own

## Indications for use
AdvanixTM Biliary Stent with NaviFlexTM 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/K101314
Methodology: https://510kreport.com/methodology