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510(k) Data Aggregation
K Number
K232596Device Name
EndoGI S-Path Biliary Stent System
Manufacturer
EndoGI Medical, Ltd.
Date Cleared
2023-09-27
(33 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
EndoGI Medical, Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoGl S-Path Biliary Stent System is intended for delivery of stent(s) to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
Device Description
The revised EndoGI S-Path System incorporates one preloaded stent which has a straight body and one end incorporating a 65° bend (duodenal bend). The stent is identical to the previously cleared EndoGI stent and is comprised of a biocompatible radiopaque plastic which allows visualization of the stent post deployment.
The EndoGI S-Path System is available 10 Fr and includes a single preloaded stent available in three lengths (80, 110 and 140 mm). The system is compatible with a guidewire of up to 0.035".
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K Number
K222627Device Name
EndoGI S-Path Biliary Stent System
Manufacturer
EndoGI Medical
Date Cleared
2022-09-28
(28 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
EndoGI Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoGI S-Path Biliary Stent System is intended for delivery of stent(s) to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
Device Description
The EndoGI S-Path Biliary Stent System consists of a stent and stent delivery catheter. The EndoGI S-Path Biliary Stent System catheter is 10 Fr in diameter and includes a single preloaded stent available in three lengths (80, 110 and 140 mm). The delivery catheter is compatible with a guidewire of up to 0.035". EndoGI S-Path Biliary System stents have a straight body and one end incorporating a 65° bend (duodenal bend). Stents are comprised of a biocompatible radiopaque plastic which allows visualization of the stent post deployment.
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K Number
K193600Device Name
EndoGI Biliary Stent System
Manufacturer
EndoGI Medical, Ltd.
Date Cleared
2020-06-26
(186 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
EndoGI Medical, Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoGI Biliary Stent System is intended for delivery of stent(s) to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
Device Description
The EndoGI System incorporates two preloaded stents. Both stents are identical in design with a straight body and one end incorporating a 65° bend (duodenal bend). The stents are comprised of a biocompatible radiopaque plastic which allows visualization of the stents post deployment. Both stents are pre-mounted on the delivery system and are delivered via near-the-wire and over-the-wire methods. The EndoGI System is available 10 Fr and includes two 110 mm stents. The system is compatible with a guidewire of up to 0.035". The safety lock mechanisms are incorporated within the delivery device handle.
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