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FDA 510(k)

MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM

K-Number: K081542 · 2008-06-27

ApplicantEntellus Medical, Inc.
Decision Date2008-06-27
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM 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 2008-06-27 under 510(k) number K081542. 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 MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM?

MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-27. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K081542.

When did MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM received FDA 510(k) clearance on 2008-06-27, under 510(k) number K081542.

Who is the listed applicant for MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM?

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 MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM?

The FDA product code for MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM 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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