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FDA 510(k)

Etherea MX

K-Number: K171443 · 2018-04-20

ApplicantVydence Medical Industria E Comercio Ltda
Decision Date2018-04-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Etherea MX is the device name listed in this FDA 510(k) record. The listed applicant is Vydence Medical Industria E Comercio Ltda. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K171443. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Etherea MX?

Etherea MX is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Vydence Medical Industria E Comercio Ltda. The 510(k) number is K171443.

When did Etherea MX receive FDA 510(k) clearance?

Etherea MX received FDA 510(k) clearance on 2018-04-20, under 510(k) number K171443.

Who is the listed applicant for Etherea MX?

The FDA 510(k) record lists Vydence Medical Industria E Comercio Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Etherea MX?

The FDA product code for Etherea MX is GEX. This falls under the Gastroenterology category.

Other records listing Vydence Medical Industria E Comercio Ltda 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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Related Devices (Code: GEX)

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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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