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FDA 510(k)

ConvertX Biliary Stent System

K-Number: K181669 · 2019-03-14

ApplicantBrightwater Medical
Decision Date2019-03-14
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ConvertX Biliary Stent System is a medical device manufactured by Brightwater Medical. It received FDA 510(k) clearance on 2019-03-14 under approval number K181669. 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 ConvertX Biliary Stent System?

ConvertX Biliary Stent System is a medical device that received FDA 510(k) clearance on 2019-03-14. It is manufactured by Brightwater Medical. The 510(k) number is K181669.

When was ConvertX Biliary Stent System approved by the FDA?

ConvertX Biliary Stent System received FDA 510(k) clearance on 2019-03-14, under approval number K181669.

What company makes ConvertX Biliary Stent System?

ConvertX Biliary Stent System is manufactured by Brightwater Medical.

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

The FDA product code for ConvertX 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 Brightwater Medical

K161277ConvertX Nephroureteral 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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