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FDA 510(k)

MICROENDOSCOPE

K-Number: K063078 · 2006-10-24

ApplicantAcclarent, Inc.
Decision Date2006-10-24
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICROENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2006-10-24 under 510(k) number K063078. 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 MICROENDOSCOPE?

MICROENDOSCOPE is a medical device that received FDA 510(k) clearance on 2006-10-24. The listed applicant is Acclarent, Inc.. The 510(k) number is K063078.

When did MICROENDOSCOPE receive FDA 510(k) clearance?

MICROENDOSCOPE received FDA 510(k) clearance on 2006-10-24, under 510(k) number K063078.

Who is the listed applicant for MICROENDOSCOPE?

The FDA 510(k) record lists Acclarent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROENDOSCOPE?

The FDA product code for MICROENDOSCOPE 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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