FDA 510(k)

Opera Evo

K-Number: K202041 · 2020-10-15

Decision Date2020-10-15

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Opera Evo is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2020-10-15 under approval number K202041. 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 Opera Evo?

Opera Evo is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Quanta System Spa. The 510(k) number is K202041.

When was Opera Evo approved by the FDA?

Opera Evo received FDA 510(k) clearance on 2020-10-15, under approval number K202041.

What company makes Opera Evo?

Opera Evo is manufactured by Quanta System Spa.

What is the FDA product code for Opera Evo?

The FDA product code for Opera Evo is GEX. This falls under the Gastroenterology category.

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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.