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FDA 510(k)

ENTELLUS MEDICAL SINUS GUIDEWIRE

K-Number: K110739 · 2011-06-14

ApplicantEntellus Medical, Inc.
Decision Date2011-06-14
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENTELLUS MEDICAL SINUS GUIDEWIRE 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 2011-06-14 under 510(k) number K110739. 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 SINUS GUIDEWIRE?

ENTELLUS MEDICAL SINUS GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2011-06-14. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K110739.

When did ENTELLUS MEDICAL SINUS GUIDEWIRE receive FDA 510(k) clearance?

ENTELLUS MEDICAL SINUS GUIDEWIRE received FDA 510(k) clearance on 2011-06-14, under 510(k) number K110739.

Who is the listed applicant for ENTELLUS MEDICAL SINUS GUIDEWIRE?

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 SINUS GUIDEWIRE?

The FDA product code for ENTELLUS MEDICAL SINUS GUIDEWIRE 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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