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X-Path Pre-loaded RX-OTW Double Biliary Stents System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- X-Path Pre-loaded RX-OTW Double Biliary Stents System FDA UDI
- Generic Name
- Polymeric biliary stent, non-bioabsorbable FDA UDI
- Device Name
- The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI Delivery System enables insertion and placement of two stents 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 Biliary Stent System is available in 10Fr and is supplied with two 110 mm stents preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope. FDA UDI
- Model / Reference
- Double-Stent FDA UDI
- Description
- The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI Delivery System enables insertion and placement of two stents 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 Biliary Stent System is available in 10Fr and is supplied with two 110 mm stents preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005738205 FDA UDI
- 510(k) Number
- K193600 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 Safe FDA UDI
Dimensions & Sizes
- Size
- Stent Length — 110 Millimeter FDA UDI
Category: Polymeric biliary stent, non-bioabsorbable
X-Path Pre-loaded RX-OTW Double Biliary Stents 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
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 10bd00aa-9fa2-48cd-8782-3a7c3da49724 37 fields · synced May 30, 2026