FDA 510(k)

EndoflipTM 300 System

Número K: K231861 · 2023-07-21

Data da decisão2023-07-21

Código do produtoFFX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

EndoflipTM 300 System is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2023-07-21 under 510(k) number K231861. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EndoflipTM 300 System?

EndoflipTM 300 System is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Covidien, LLC. The 510(k) number is K231861.

When did EndoflipTM 300 System receive FDA 510(k) clearance?

EndoflipTM 300 System received FDA 510(k) clearance on 2023-07-21, under 510(k) number K231861.

Who is the listed applicant for EndoflipTM 300 System?

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

What is the FDA product code for EndoflipTM 300 System?

The FDA product code for EndoflipTM 300 System is FFX.

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Fonte oficial

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