Duns Number:532316194
Device Description: The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the 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.
Catalog Number
-
Brand Name
S-Path Pre-loaded RX Biliary Stent System
Version/Model Number
Single-Stent
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K202477,K202477
Product Code
FGE
Product Code Name
Stents, Drains And Dilators For The Biliary Ducts
Public Device Record Key
4c0f1a9a-fe88-406f-82ed-9f7de90d5a7c
Public Version Date
December 09, 2020
Public Version Number
1
DI Record Publish Date
December 01, 2020
Package DI Number
10860005738219
Quantity per Package
10
Contains DI Package
00860005738212
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |