FDA 510(k)

cortiQ PRO

K-Number: K191432 · 2020-01-24

Decision Date2020-01-24

Product CodeOLU

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

cortiQ PRO is the device name listed in this FDA 510(k) record. The listed applicant is G.Tec Medical Engineering GmbH. It received FDA 510(k) clearance on 2020-01-24 under 510(k) number K191432. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cortiQ PRO?

cortiQ PRO is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is G.Tec Medical Engineering GmbH. The 510(k) number is K191432.

When did cortiQ PRO receive FDA 510(k) clearance?

cortiQ PRO received FDA 510(k) clearance on 2020-01-24, under 510(k) number K191432.

Who is the listed applicant for cortiQ PRO?

The FDA 510(k) record lists G.Tec Medical Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cortiQ PRO?

The FDA product code for cortiQ PRO is OLU.

Other records listing G.Tec Medical Engineering GmbH 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.