FDA 510(k)

EndoGI Biliary Stent System

K-Number: K193600 · 2020-06-26

Decision Date2020-06-26

Product CodeFGE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EndoGI Biliary Stent System is a medical device manufactured by Endogi Medical, Ltd.. It received FDA 510(k) clearance on 2020-06-26 under approval number K193600. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoGI Biliary Stent System?

EndoGI Biliary Stent System is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by Endogi Medical, Ltd.. The 510(k) number is K193600.

When was EndoGI Biliary Stent System approved by the FDA?

EndoGI Biliary Stent System received FDA 510(k) clearance on 2020-06-26, under approval number K193600.

What company makes EndoGI Biliary Stent System?

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

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

The FDA product code for EndoGI 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

Other Devices by Endogi Medical, Ltd.

K232596EndoGI S-Path 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

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