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FDA 510(k)

GSI Corti

K-Number: K180287 · 2018-05-11

ApplicantGrason-Stadler, Inc.
Decision Date2018-05-11
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GSI Corti is a medical device manufactured by Grason-Stadler, Inc.. It received FDA 510(k) clearance on 2018-05-11 under approval number K180287. 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 Corti?

GSI Corti is a medical device that received FDA 510(k) clearance on 2018-05-11. It is manufactured by Grason-Stadler, Inc.. The 510(k) number is K180287.

When was GSI Corti approved by the FDA?

GSI Corti received FDA 510(k) clearance on 2018-05-11, under approval number K180287.

What company makes GSI Corti?

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

What is the FDA product code for GSI Corti?

The FDA product code for GSI Corti is EWO.

Other Devices by Grason-Stadler, Inc.

K172403GSI Novus

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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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