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FDA 510(k)

FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)

K-Number: K091681 · 2009-07-08

ApplicantEntellus Medical, Inc.
Decision Date2009-07-08
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) 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 2009-07-08 under 510(k) number K091681. 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 FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)?

FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) is a medical device that received FDA 510(k) clearance on 2009-07-08. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K091681.

When did FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) receive FDA 510(k) clearance?

FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) received FDA 510(k) clearance on 2009-07-08, under 510(k) number K091681.

Who is the listed applicant for FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)?

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 FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)?

The FDA product code for FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) 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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