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FDA 510(k)

ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE

K-Number: K100577 · 2011-01-06

ApplicantAcclarent, Inc.
Decision Date2011-01-06
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2011-01-06 under 510(k) number K100577. 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 ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE?

ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE is a medical device that received FDA 510(k) clearance on 2011-01-06. The listed applicant is Acclarent, Inc.. The 510(k) number is K100577.

When did ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE receive FDA 510(k) clearance?

ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE received FDA 510(k) clearance on 2011-01-06, under 510(k) number K100577.

Who is the listed applicant for ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE?

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 ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE?

The FDA product code for ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE is EOB.

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Other records listing Acclarent, Inc. as applicant

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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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