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FDA 510(k)

PATHASSIT LIGHT SEEKER

K-Number: K120735 · 2012-04-02

ApplicantEntellus Medical, Inc.
Decision Date2012-04-02
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PATHASSIT LIGHT SEEKER 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 2012-04-02 under 510(k) number K120735. 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 PATHASSIT LIGHT SEEKER?

PATHASSIT LIGHT SEEKER is a medical device that received FDA 510(k) clearance on 2012-04-02. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K120735.

When did PATHASSIT LIGHT SEEKER receive FDA 510(k) clearance?

PATHASSIT LIGHT SEEKER received FDA 510(k) clearance on 2012-04-02, under 510(k) number K120735.

Who is the listed applicant for PATHASSIT LIGHT SEEKER?

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 PATHASSIT LIGHT SEEKER?

The FDA product code for PATHASSIT LIGHT SEEKER is LRC.

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Other records listing Entellus Medical, Inc. as applicant

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.

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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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