S-Path Pre-Loaded RX Biliary Stent System
The EndoGI S-Path Pre-loaded RX Biliary Stent System delivers a stent into the biliary tract. It is intended to drain bile ducts, splint a duct during healing, or maintain an open passage…
The EndoGI S-Path Pre-loaded RX Biliary Stent System delivers a stent into the biliary tract. It is intended to drain bile ducts, splint a duct during healing, or maintain an open passage through a stricture or past a stone.
The 10 French system carries one preloaded stent measuring 110 millimetres long. The stent has a straight body and a 65-degree bend at one end. Its radiopaque plastic construction allows it to be visualized after deployment.
Listed Item
The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent 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 S-Path Pre-loaded RX Biliary Stent System is available in 10Fr and is supplied with one 110 mm stent preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.
Guidewire Compatibility
The delivery system is compatible with guidewires up to 0.035 inches in diameter.
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Endo GI Medical, Israel |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| 510(k) | K202477 |
| Record published | 2020-12-01 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 5 to 40 °C |
| Packaging | Pack of 10 |
| Sizes | Stent length 110 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Single-Stent | Stent Length 110 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zimmon | Cook Ireland Ltd | 213 |
| Single Use Biliary Drainage Stent V | Olympus Medical Systems Corp. | 181 |
| Mustang™ | Boston Scientific Corporation | 167 |
| Geenen | Cook Ireland Ltd | 158 |
| Cotton-Leung | Cook Ireland Ltd | 144 |
| Advanix™ Pancreatic Stent | Boston Scientific Corporation | 135 |
| Single Use Biliary Stent V | Olympus Medical Systems Corp. | 106 |
| Single-use Balloon Dilatation Catheter | LEO Medical Co., Ltd. | 102 |
| Biliary Plastic Stent Set | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| Biliary Plastic Stent | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| M-Drain | Mermaid Medical A/S | 86 |
| Advanix™ Biliary | Boston Scientific Corporation | 84 |
Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222627 | 2022-09-28 |
| K202477 | 2020-09-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.