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FDA 510(k)

Next Generation Balloon Dilation System

K-Number: K201115 · 2020-08-27

ApplicantAcclarent, Inc.
Decision Date2020-08-27
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Next Generation Balloon Dilation System is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2020-08-27 under approval number K201115. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Next Generation Balloon Dilation System?

Next Generation Balloon Dilation System is a medical device that received FDA 510(k) clearance on 2020-08-27. It is manufactured by Acclarent, Inc.. The 510(k) number is K201115.

When was Next Generation Balloon Dilation System approved by the FDA?

Next Generation Balloon Dilation System received FDA 510(k) clearance on 2020-08-27, under approval number K201115.

What company makes Next Generation Balloon Dilation System?

Next Generation Balloon Dilation System is manufactured by Acclarent, Inc..

What is the FDA product code for Next Generation Balloon Dilation System?

The FDA product code for Next Generation Balloon Dilation System is LRC.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING 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Balloon System (Abbreviated as'Orbera365') NOT_YET_RECRUITING NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT07181590 BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF RECRUITING NCT07211035 Effect of the Amplifi™ Vein Dilation System on Outflow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

Related PubMed Literature

PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025)

Other Devices by Acclarent, Inc.

K161697Acclarent NavWire Sinus Navigation Guidewire K161698Relieva UltirraNav Sinus Balloon Catheter DEN150056Acclarent Aera Eustachian Tube Balloon Dilation System K153341Relieva Scout Multi-Sinus Dilation System K171687Relieva SpinPlus Nav Balloon Sinuplasty System K180948TruDi NAV Suction Instruments

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Related Devices (Code: LRC)

K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc. K160770Vent-Os Sinus Dilation familySinusys Corporation K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc. K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc. K181838Sinusway Dilation System3nt Medical , Ltd.

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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