Is this your brand? Sign in to claim ownership.
Sign in to claim this brandEndo GI Medical
US
Last updated May 23, 2026
What Endo GI Medical makes
Endo GI Medical manufactures non-bioabsorbable polymeric biliary stents designed for biliary drainage and obstruction management. Their portfolio includes pre-loaded stent systems and delivery devices tailored for biliary procedures, such as the S-Path and X-Path series, which vary in length and configuration for specific clinical needs.
These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearance and listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Endo GI Medical primarily manufacture?
Endo GI Medical specializes in non-bioabsorbable polymeric biliary stents. These devices are specifically designed for biliary drainage and managing obstructions in the bile ducts. Their product line includes pre-loaded stent systems and delivery devices, such as the S-Path and X-Path series, which come in various lengths and configurations to address different clinical needs.
Where is Endo GI Medical based, and what does that mean for regulatory oversight?
Endo GI Medical is based in the United States. Since the company operates within the US, its devices are subject to FDA regulatory oversight. The FDA classifies these devices as Class II, indicating a moderate level of risk that requires special controls to ensure safety and effectiveness before authorisation.
Which regulatory registries or databases list Endo GI Medical’s devices?
Endo GI Medical’s devices are authorised through the FDA’s 510(k) clearance process, which demonstrates that they meet regulatory requirements for safety and performance. Additionally, these devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and transparency in the medical device supply chain.
How are Endo GI Medical’s devices classified under FDA regulations?
Endo GI Medical’s biliary stents fall under FDA Class II classification. This classification is assigned based on the level of risk associated with the device. Class II devices require special controls beyond general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance, before they can be authorised for use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| S-Path Pre-loaded RX Biliary Stent System | Single-Stent | FDA UDI | Class II | Active |
| X-Path Pre-loaded RX-OTW Double Biliary Stents System | Double-Stent | FDA UDI | Class II | Active |
| S-Path Biliary Stent System (140mm) | Single-Stent (140mm) | FDA UDI | Class II | Active |
| S-Path Pre-loaded RX Biliary Stent System (80mm) | Single-Stent (80mm) | FDA UDI | Class II | Active |
| EndoGI Specialized S-Path Delivery System | Delivery System | FDA UDI | Class II | Active |
| EndoGI Specialized S-Path Delivery System | Delivery System | FDA UDI | Class II | Active |
| EndoGI Biliary Stent System | K193600 | FDA 510(k) | Class II | Active |
| EndoGI S-Path Biliary Stent System | K232596 | FDA 510(k) | Class II | Active |
| EndoGI S-Path Biliary Stent System | K222627 | FDA 510(k) | Class II | Active |
| EndoGI S-Path Biliary Stent System | K202477 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Endogi Medical, Ltd. Nazareth Northern · IL FEI 3016463905