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FDA 510(k)

PATHASSIST LED LIGHT FIBER

K-Number: K130503 · 2013-06-11

ApplicantEntellus Medical, Inc.
Decision Date2013-06-11
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PATHASSIST LED 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 2013-06-11 under 510(k) number K130503. 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 LED LIGHT FIBER?

PATHASSIST LED LIGHT FIBER is a medical device that received FDA 510(k) clearance on 2013-06-11. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K130503.

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

PATHASSIST LED LIGHT FIBER received FDA 510(k) clearance on 2013-06-11, under 510(k) number K130503.

Who is the listed applicant for PATHASSIST LED 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 LED LIGHT FIBER?

The FDA product code for PATHASSIST LED 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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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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