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FDA 510(k)

ALVUE Balloon Dilation System

K-Number: K171939 · 2018-03-07

ApplicantGlobus Medical, Inc.
Decision Date2018-03-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALVUE Balloon Dilation System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2018-03-07 under approval number K171939. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALVUE Balloon Dilation System?

ALVUE Balloon Dilation System is a medical device that received FDA 510(k) clearance on 2018-03-07. It is manufactured by Globus Medical, Inc.. The 510(k) number is K171939.

When was ALVUE Balloon Dilation System approved by the FDA?

ALVUE Balloon Dilation System received FDA 510(k) clearance on 2018-03-07, under approval number K171939.

What company makes ALVUE Balloon Dilation System?

ALVUE Balloon Dilation System is manufactured by Globus Medical, Inc..

What is the FDA product code for ALVUE Balloon Dilation System?

The FDA product code for ALVUE Balloon Dilation System is GCJ.

Related Clinical Trials

NCT07195708 Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') NOT_YET_RECRUITING NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT07181590 BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF RECRUITING NCT07211035 Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1) RECRUITING NCT07599826 Active vs. Passive VR During Office-based ENT Procedures NOT_YET_RECRUITING NCT07062094 Safety and Effectiveness of Orbera365™ Intragastric Balloon System RECRUITING

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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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