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FDA 510(k)

EndoGI S-Path Biliary Stent System

K-Number: K222627 · 2022-09-28

ApplicantEndo GI Medical
Decision Date2022-09-28
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoGI S-Path Biliary Stent System is a medical device manufactured by Endo GI Medical. It received FDA 510(k) clearance on 2022-09-28 under approval number K222627. 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 S-Path Biliary Stent System?

EndoGI S-Path Biliary Stent System is a medical device that received FDA 510(k) clearance on 2022-09-28. It is manufactured by Endo GI Medical. The 510(k) number is K222627.

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

EndoGI S-Path Biliary Stent System received FDA 510(k) clearance on 2022-09-28, under approval number K222627.

What company makes EndoGI S-Path Biliary Stent System?

EndoGI S-Path Biliary Stent System is manufactured by Endo GI Medical.

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 Endo GI Medical

K202477EndoGI 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

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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