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FDA 510(k)

ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE

K-Number: K082569 · 2008-09-18

ApplicantEntellus Medical, Inc.
Decision Date2008-09-18
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE 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 2008-09-18 under 510(k) number K082569. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE?

ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE is a medical device that received FDA 510(k) clearance on 2008-09-18. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K082569.

When did ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE receive FDA 510(k) clearance?

ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE received FDA 510(k) clearance on 2008-09-18, under 510(k) number K082569.

Who is the listed applicant for ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE?

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 ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE?

The FDA product code for ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE is EOB.

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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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