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FDA 510(k)

EndoGI S-Path Biliary Stent System

K-Number: K232596 · 2023-09-27

ApplicantEndogi Medical, Ltd.
Decision Date2023-09-27
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

EndoGI S-Path Biliary Stent System is a medical device manufactured by Endogi Medical, Ltd.. It received FDA 510(k) clearance on 2023-09-27 under approval number K232596. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the EndoGI S-Path Biliary Stent System?

EndoGI S-Path Biliary Stent System is a medical device that received FDA 510(k) clearance on 2023-09-27. It is manufactured by Endogi Medical, Ltd.. The 510(k) number is K232596.

When was EndoGI S-Path Biliary Stent System approved by the FDA?

EndoGI S-Path Biliary Stent System received FDA 510(k) clearance on 2023-09-27, under approval number K232596.

What company makes EndoGI S-Path Biliary Stent System?

EndoGI S-Path Biliary Stent System is manufactured by Endogi Medical, Ltd..

What is the FDA product code for EndoGI S-Path Biliary Stent System?

The FDA product code for EndoGI S-Path Biliary Stent System is FGE.

Related Clinical Trials

NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT07607353 Biodegradable Stents in Primary Sclerosing Cholangitis RECRUITING NCT07611968 Prospective Evaluation of Physician Modified Endografts for Aortic Disease NOT_YET_RECRUITING NCT05864560 Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up ACTIVE_NOT_RECRUITING NCT05546372 Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma RECRUITING NCT05639569 Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 25262248 Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration. American heart journal (2014)

Other Devices by Endogi Medical, Ltd.

K193600EndoGI Biliary Stent System

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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