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FDA 510(k)

AED Sinuscope

K-Number: K170285 · 2017-08-01

ApplicantNational Advanced Endoscopy Devices, Inc.
Decision Date2017-08-01
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AED Sinuscope is a medical device manufactured by National Advanced Endoscopy Devices, Inc.. It received FDA 510(k) clearance on 2017-08-01 under approval number K170285. 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 AED Sinuscope?

AED Sinuscope is a medical device that received FDA 510(k) clearance on 2017-08-01. It is manufactured by National Advanced Endoscopy Devices, Inc.. The 510(k) number is K170285.

When was AED Sinuscope approved by the FDA?

AED Sinuscope received FDA 510(k) clearance on 2017-08-01, under approval number K170285.

What company makes AED Sinuscope?

AED Sinuscope is manufactured by National Advanced Endoscopy Devices, Inc..

What is the FDA product code for AED Sinuscope?

The FDA product code for AED Sinuscope 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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