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FDA 510(k)

PATHASSIST LIGHT FIBER

K-Number: K120962 · 2012-04-27

ApplicantEntellus Medical, Inc.
Decision Date2012-04-27
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PATHASSIST LIGHT FIBER 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 2012-04-27 under 510(k) number K120962. 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 PATHASSIST LIGHT FIBER?

PATHASSIST LIGHT FIBER is a medical device that received FDA 510(k) clearance on 2012-04-27. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K120962.

When did PATHASSIST LIGHT FIBER receive FDA 510(k) clearance?

PATHASSIST LIGHT FIBER received FDA 510(k) clearance on 2012-04-27, under 510(k) number K120962.

Who is the listed applicant for PATHASSIST LIGHT FIBER?

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 PATHASSIST LIGHT FIBER?

The FDA product code for PATHASSIST LIGHT FIBER 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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