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FDA 510(k)

Express SD Biliary Monorail Premounted Stent System

K-Number: K162404 · 2016-10-12

ApplicantBoston Scientific Corporation
Decision Date2016-10-12
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Express SD Biliary Monorail Premounted Stent System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-10-12 under approval number K162404. 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 Express SD Biliary Monorail Premounted Stent System?

Express SD Biliary Monorail Premounted Stent System is a medical device that received FDA 510(k) clearance on 2016-10-12. It is manufactured by Boston Scientific Corporation. The 510(k) number is K162404.

When was Express SD Biliary Monorail Premounted Stent System approved by the FDA?

Express SD Biliary Monorail Premounted Stent System received FDA 510(k) clearance on 2016-10-12, under approval number K162404.

What company makes Express SD Biliary Monorail Premounted Stent System?

Express SD Biliary Monorail Premounted Stent System is manufactured by Boston Scientific Corporation.

What is the FDA product code for Express SD Biliary Monorail Premounted Stent System?

The FDA product code for Express SD Biliary Monorail Premounted 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 Boston Scientific Corporation

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete K163174Emerge PTCA Dilatation Catheter K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 K160823NC Quantum Apex PTCA Dilatation Catheter K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter K161003EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector

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Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. 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 K171809Epic Biliary Endoscopic Stent SystemBoston 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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