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FDA 510(k)

GSI Novus

K-Number: K172403 · 2017-10-20

ApplicantGrason-Stadler, Inc.
Decision Date2017-10-20
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GSI Novus is a medical device manufactured by Grason-Stadler, Inc.. It received FDA 510(k) clearance on 2017-10-20 under approval number K172403. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSI Novus?

GSI Novus is a medical device that received FDA 510(k) clearance on 2017-10-20. It is manufactured by Grason-Stadler, Inc.. The 510(k) number is K172403.

When was GSI Novus approved by the FDA?

GSI Novus received FDA 510(k) clearance on 2017-10-20, under approval number K172403.

What company makes GSI Novus?

GSI Novus is manufactured by Grason-Stadler, Inc..

What is the FDA product code for GSI Novus?

The FDA product code for GSI Novus is EWO.

Other Devices by Grason-Stadler, Inc.

K180287GSI Corti

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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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