FDA 510(k)

EEA Circular Stapler with Tri-Staple Technology

Número K: K221005 · 2022-04-29

Data da decisão2022-04-29

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

EEA Circular Stapler with Tri-Staple Technology is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K221005. 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 EEA Circular Stapler with Tri-Staple Technology?

EEA Circular Stapler with Tri-Staple Technology is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Covidien. The 510(k) number is K221005.

When did EEA Circular Stapler with Tri-Staple Technology receive FDA 510(k) clearance?

EEA Circular Stapler with Tri-Staple Technology received FDA 510(k) clearance on 2022-04-29, under 510(k) number K221005.

Who is the listed applicant for EEA Circular Stapler with Tri-Staple Technology?

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

What is the FDA product code for EEA Circular Stapler with Tri-Staple Technology?

The FDA product code for EEA Circular Stapler with Tri-Staple Technology is GDW.

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Dispositivos Relacionados (Código: GDW)

Fonte oficial

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