# K232596: EndoGI S-Path Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Endogi Medical, Ltd.
- Decided: Sep 27, 2023 after 33 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: 6 generations back to K834468 (1984). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222627: EndoGI S-Path Biliary Stent System, Endo GI Medical (2022) Summary page 5.
- K202477: EndoGI S-Path Biliary Stent System, Endo GI Medical (2020) Summary page 5.
- K193600: EndoGI Biliary Stent System, Endogi Medical, Ltd. (2020) Summary page 5.

## Indications for use
The EndoGl S-Path 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/K232596
Methodology: https://510kreport.com/methodology