EndoGI Specialized S-Path Delivery System

GUDID 00860005738243

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).

ENDO GI MEDICAL LTD

Polymeric biliary stent, non-bioabsorbable

• Primary Device ID: 00860005738243
• NIH Device Record Key: 17bf1b39-4e8f-47e6-80f5-ae54c11396c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoGI Specialized S-Path Delivery System
• Version Model Number: Delivery System
• Company DUNS: 532316194
• Company Name: ENDO GI MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com
• Phone: +97246098600
• Email: omri@endogi-medical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005738243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232596

FDA Product Code

• FGE: Stents, Drains And Dilators For The Biliary Ducts

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-31
• Device Publish Date: 2025-03-21

Devices Manufactured by ENDO GI MEDICAL LTD

• 00860005738243 - EndoGI Specialized S-Path Delivery System: 2025-03-31The 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).
• 00860005738243 - EndoGI Specialized S-Path Delivery System: 2025-03-31 The EndoGI Specialized S-Path Biliary Delivery System is designed for the deployment of Pigtail Biliary stent enabling drainage
• 00860005738229 - S-Path Pre-loaded RX Biliary Stent System (80mm): 2023-09-05 The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainag
• 00860005738236 - S-Path Biliary Stent System (140mm): 2023-09-05 The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainag
• 00860005738205 - X-Path Pre-loaded RX-OTW Double Biliary Stents System: 2020-12-09 The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) e
• 10860005738219 - S-Path Pre-loaded RX Biliary Stent System: 2020-12-09 The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainag