EndoGI Specialized S-Path Delivery System

Basic Information

• Brand Name: EndoGI Specialized S-Path Delivery System
• Primary DI: 00860005738250
• Version / Model: Delivery System
• Company Name: ENDO GI MEDICAL LTD
• Labeler DUNS: 532316194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-07
• Public Version: 1
• Public Version Date: 2025-04-15
• Public Version Status: New
• Public Device Record Key: 496ec95c-a13b-41cd-8922-8fda26ee905b

Device Description

The EndoGI Specialized S-Path Biliary Delivery System is designed for the deployment of Pigtail Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The EndoGI S-Path Delivery System enables insertion and placement of one stent in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site. The EndoGI Specialized S-Path Biliary Delivery System is to be loaded with a compatible pigtail stent prior to use. The system is compatible with a 10Fr (2.4 mm inner diameter and 3.4mm outer diameter) pigtail stent with a length of 7 cm (total length up to 20 cm).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43764	Polymeric biliary stent, non-bioabsorbable	A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860005738250	GS1
Package	10860005738257	GS1		10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K232596	000