# K193600: EndoGI Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Endogi Medical, Ltd.
- Decided: Jun 26, 2020 after 186 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.
3 later devices descend from it; 2 cite it directly.
0 of 8 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
- K202477: EndoGI S-Path Biliary Stent System (2020), 2 descendants of its own
- K222627: EndoGI S-Path Biliary Stent System (2022), 1 descendant of its own
- K232596: EndoGI S-Path Biliary Stent System (2023), 0 descendants of its own

## Indications for use
The EndoGI Biliary Stent System is intended for delivery of stent(s) 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/K193600
Methodology: https://510kreport.com/methodology