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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 the device name listed in this FDA 510(k) record. The listed applicant is National Advanced Endoscopy Devices, Inc.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) 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. The listed applicant is National Advanced Endoscopy Devices, Inc.. The 510(k) number is K170285.

When did AED Sinuscope receive FDA 510(k) clearance?

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

Who is the listed applicant for AED Sinuscope?

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

What is the FDA product code for AED Sinuscope?

The FDA product code for AED Sinuscope is EOB.

Related Devices (Code: EOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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