FDA 510(k)

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)

Número K: K221629 · 2023-02-22

Data da decisão2023-02-22

Código do produtoGAG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K221629. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)?

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Covidien. The 510(k) number is K221629.

When did Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) receive FDA 510(k) clearance?

Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) received FDA 510(k) clearance on 2023-02-22, under 510(k) number K221629.

Who is the listed applicant for Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)?

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 Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)?

The FDA product code for Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) is GAG.

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Dispositivos Relacionados (Código: GAG)

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Fonte oficial

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