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FDA 510(k)

Leonardo Mini Blue

K-Number: K210951 · 2021-09-01

ApplicantCeramoptec GmbH
Decision Date2021-09-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Leonardo Mini Blue is the device name listed in this FDA 510(k) record. The listed applicant is Ceramoptec GmbH. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K210951. 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 Leonardo Mini Blue?

Leonardo Mini Blue is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Ceramoptec GmbH. The 510(k) number is K210951.

When did Leonardo Mini Blue receive FDA 510(k) clearance?

Leonardo Mini Blue received FDA 510(k) clearance on 2021-09-01, under 510(k) number K210951.

Who is the listed applicant for Leonardo Mini Blue?

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

What is the FDA product code for Leonardo Mini Blue?

The FDA product code for Leonardo Mini Blue is GEX. This falls under the Gastroenterology category.

Other records listing Ceramoptec 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.

K250504Leonardo Duster

Related Devices (Code: GEX)

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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