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FDA 510(k)

RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM

K-Number: K120280 · 2012-11-05

ApplicantAcclarent, Inc.
Decision Date2012-11-05
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RELIEVA SEEKER BALLOON SINUPLASTY 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 2012-11-05 under 510(k) number K120280. 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 RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM?

RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-05. The listed applicant is Acclarent, Inc.. The 510(k) number is K120280.

When did RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM receive FDA 510(k) clearance?

RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM received FDA 510(k) clearance on 2012-11-05, under 510(k) number K120280.

Who is the listed applicant for RELIEVA SEEKER BALLOON SINUPLASTY 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 RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM?

The FDA product code for RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM is LRC.

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Other records listing Acclarent, Inc. as applicant

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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 EntK201115Next Generation Balloon Dilation SystemAcclarent, Inc.K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbHK181546Dillard Nasal Balloon CatheterIntuit Medical Products, LLC

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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