FDA 510(k)

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed

Número K: K201280 · 2020-07-27

Data da decisão2020-07-27

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2020-07-27 under 510(k) number K201280. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed?

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed is a medical device that received FDA 510(k) clearance on 2020-07-27. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K201280.

When did Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed receive FDA 510(k) clearance?

Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed received FDA 510(k) clearance on 2020-07-27, under 510(k) number K201280.

Who is the listed applicant for Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed?

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

What is the FDA product code for Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed?

The FDA product code for Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed is GDW.

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Fonte oficial

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