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FDA 510(k)

Aquas Probes

K-Number: K190168 · 2019-03-14

ApplicantGenicon, Inc.
Decision Date2019-03-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aquas Probes is the device name listed in this FDA 510(k) record. The listed applicant is Genicon, Inc.. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K190168. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aquas Probes?

Aquas Probes is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Genicon, Inc.. The 510(k) number is K190168.

When did Aquas Probes receive FDA 510(k) clearance?

Aquas Probes received FDA 510(k) clearance on 2019-03-14, under 510(k) number K190168.

Who is the listed applicant for Aquas Probes?

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

What is the FDA product code for Aquas Probes?

The FDA product code for Aquas Probes is GEI.

Other records listing Genicon, 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.

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