FDA 510(k)

GSI Corti

K-Number: K180287 · 2018-05-11

Decision Date2018-05-11

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

GSI Corti 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 2018-05-11 under 510(k) 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. The listed applicant is Grason-Stadler, Inc.. The 510(k) number is K180287.

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

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

Who is the listed applicant for GSI Corti?

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 Corti?

The FDA product code for GSI Corti 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.

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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.