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FDA 510(k)

EGIS Biliary Single Bare Stent

K-Number: K223354 · 2023-09-21

ApplicantS&G Biotech, Inc.
Decision Date2023-09-21
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

EGIS Biliary Single Bare Stent is a medical device manufactured by S&G Biotech, Inc.. It received FDA 510(k) clearance on 2023-09-21 under approval number K223354. 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 EGIS Biliary Single Bare Stent?

EGIS Biliary Single Bare Stent is a medical device that received FDA 510(k) clearance on 2023-09-21. It is manufactured by S&G Biotech, Inc.. The 510(k) number is K223354.

When was EGIS Biliary Single Bare Stent approved by the FDA?

EGIS Biliary Single Bare Stent received FDA 510(k) clearance on 2023-09-21, under approval number K223354.

What company makes EGIS Biliary Single Bare Stent?

EGIS Biliary Single Bare Stent is manufactured by S&G Biotech, Inc..

What is the FDA product code for EGIS Biliary Single Bare Stent?

The FDA product code for EGIS Biliary Single Bare Stent 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 NCT05546372 Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma RECRUITING NCT05874934 Endoscopic Drainage of Presumed Resectable pCCA Using an Intrahepatic Plastic Stent With Retrieval String COMPLETED NCT06710938 Thoracoabdominal Artery Stent Graft System Exploratory Study RECRUITING NCT07606430 Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction NOT_YET_RECRUITING

Other Devices by S&G Biotech, Inc.

K242845EGIS Biliary Double Bare Stent (BDB080405)

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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