FDA 510(k)

ULYSS Multi View Sinuscope

K-Number: K153701 · 2016-09-09

Decision Date2016-09-09

Product CodeEOB

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

ULYSS Multi View Sinuscope is a medical device manufactured by Sopro-Comeg GmbH. It received FDA 510(k) clearance on 2016-09-09 under approval number K153701. 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 ULYSS Multi View Sinuscope?

ULYSS Multi View Sinuscope is a medical device that received FDA 510(k) clearance on 2016-09-09. It is manufactured by Sopro-Comeg GmbH. The 510(k) number is K153701.

When was ULYSS Multi View Sinuscope approved by the FDA?

ULYSS Multi View Sinuscope received FDA 510(k) clearance on 2016-09-09, under approval number K153701.

What company makes ULYSS Multi View Sinuscope?

ULYSS Multi View Sinuscope is manufactured by Sopro-Comeg GmbH.

What is the FDA product code for ULYSS Multi View Sinuscope?

The FDA product code for ULYSS Multi View Sinuscope is EOB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.