FDA 510(k)

Cryo 7

Número K: K220020 · 2022-02-04

Data da decisão2022-02-04

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cryo 7 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K220020. 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.

Perguntas frequentes

What is the Cryo 7?

Cryo 7 is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K220020.

When did Cryo 7 receive FDA 510(k) clearance?

Cryo 7 received FDA 510(k) clearance on 2022-02-04, under 510(k) number K220020.

Who is the listed applicant for Cryo 7?

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

What is the FDA product code for Cryo 7?

The FDA product code for Cryo 7 is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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