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FDA 510(k)

ENTELLUS MEDICAL BALLOON DEVICE

K-Number: K093007 · 2010-02-05

ApplicantEntellus Medical, Inc.
Decision Date2010-02-05
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENTELLUS MEDICAL BALLOON DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Entellus Medical, Inc.. It received FDA 510(k) clearance on 2010-02-05 under 510(k) number K093007. 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 ENTELLUS MEDICAL BALLOON DEVICE?

ENTELLUS MEDICAL BALLOON DEVICE is a medical device that received FDA 510(k) clearance on 2010-02-05. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K093007.

When did ENTELLUS MEDICAL BALLOON DEVICE receive FDA 510(k) clearance?

ENTELLUS MEDICAL BALLOON DEVICE received FDA 510(k) clearance on 2010-02-05, under 510(k) number K093007.

Who is the listed applicant for ENTELLUS MEDICAL BALLOON DEVICE?

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

What is the FDA product code for ENTELLUS MEDICAL BALLOON DEVICE?

The FDA product code for ENTELLUS MEDICAL BALLOON DEVICE is LRC.

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Other records listing Entellus Medical, Inc. as applicant

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Related Devices (Code: LRC)

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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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