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FDA 510(k)

Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V

K-Number: K223404 · 2023-01-20

ApplicantQuanta System Spa
Decision Date2023-01-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K223404. 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 Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V?

Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Quanta System Spa. The 510(k) number is K223404.

When did Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V receive FDA 510(k) clearance?

Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V received FDA 510(k) clearance on 2023-01-20, under 510(k) number K223404.

Who is the listed applicant for Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V?

The FDA 510(k) record lists Quanta System Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V?

The FDA product code for Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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