Identity
- Trade Name
- EndoGI Specialized S-Path Delivery System FDA UDI
- Generic Name
- Polymeric biliary stent, non-bioabsorbable FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- Delivery System FDA UDI
- 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). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005738243 FDA UDI
- 510(k) Number
- K232596 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Polymeric biliary stent, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Polymeric biliary stent, non-bioabsorbable
EndoGI Specialized S-Path Delivery System by Endo GI Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric biliary stent, non-bioabsorbable.
- RX Biliary — Boston Scientific · Class II
- Single Use Biliary Drainage Stent V — Olympus Medical Systems Corporation · Class II
- Oasis — Cook Ireland, Ltd. · Class II
- Cotton-Huibregtse — Cook Ireland, Ltd. · Class II
- Single Use Biliary Drainage Stent V — Olympus Medical Systems Corporation · Class II
- Advanix™ Biliary — Boston Scientific · Class II
- Single Use Biliary Drainage Stent V — Olympus Medical Systems Corporation · Class II
- Single Use Biliary Drainage Stent V — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K232596 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Endo GI Medical
Sources (1)
- FDA UDI 17bf1b39-4e8f-47e6-80f5-ae54c11396c3 36 fields · synced May 30, 2026