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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 the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2020-08-27 under 510(k) 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. The listed applicant is Acclarent, Inc.. The 510(k) number is K201115.

When did Next Generation Balloon Dilation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Next Generation Balloon Dilation System?

The FDA 510(k) record lists Acclarent, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Acclarent, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemK230742ACCLARENT AERA Eustachian Tube Dilation SystemK231862TruDi® Navigation System V3 (FG-2000-00)K221037TruDi Shaver BladeK201174TruDi CuretteK193453TruDi Probe

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Related Devices (Code: LRC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230258BB 8 Sinus Dilation KitExcelent, Inc.K212774VenSure LightGuideIntersect Ent.K201398SINUSPRIME Dilation SystemStryker EntK201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbHK181546Dillard Nasal Balloon CatheterIntuit Medical Products, LLCK190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.

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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