FDA 510(k)

GSI Novus

K-Number: K172403 · 2017-10-20

Decision Date2017-10-20

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

GSI Novus is the device name listed in this FDA 510(k) record. The listed applicant is Grason-Stadler, Inc.. It received FDA 510(k) clearance on 2017-10-20 under 510(k) 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. The listed applicant is Grason-Stadler, Inc.. The 510(k) number is K172403.

When did GSI Novus receive FDA 510(k) clearance?

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

Who is the listed applicant for GSI Novus?

The FDA 510(k) record lists Grason-Stadler, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GSI Novus?

The FDA product code for GSI Novus is EWO.

Other records listing Grason-Stadler, Inc. as applicant

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.

K193033GSI Audera Pro K180287GSI Corti

Related Devices (Code: EWO)

K234095OtoNova/OtoNova ProOtodynamics K240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH K191372LyraInteracoustics A/S K180287GSI CortiGrason-Stadler, Inc.

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.