Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Advanix Biliary Stent with NaviFlex RX Delivery System

K-Number: K203162 · 2020-12-18

ApplicantBoston Scientific Corporation
Decision Date2020-12-18
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Advanix Biliary Stent with NaviFlex RX Delivery System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-12-18 under approval number K203162. 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 Advanix Biliary Stent with NaviFlex RX Delivery System?

Advanix Biliary Stent with NaviFlex RX Delivery System is a medical device that received FDA 510(k) clearance on 2020-12-18. It is manufactured by Boston Scientific Corporation. The 510(k) number is K203162.

When was Advanix Biliary Stent with NaviFlex RX Delivery System approved by the FDA?

Advanix Biliary Stent with NaviFlex RX Delivery System received FDA 510(k) clearance on 2020-12-18, under approval number K203162.

What company makes Advanix Biliary Stent with NaviFlex RX Delivery System?

Advanix Biliary Stent with NaviFlex RX Delivery System is manufactured by Boston Scientific Corporation.

What is the FDA product code for Advanix Biliary Stent with NaviFlex RX Delivery System?

The FDA product code for Advanix Biliary Stent with NaviFlex RX Delivery 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 NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07611968 Prospective Evaluation of Physician Modified Endografts for Aortic Disease NOT_YET_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 K162404Express SD Biliary Monorail Premounted Stent System K160823NC Quantum Apex PTCA Dilatation Catheter K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter

View all 176 devices →

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.

↑