FDA 510(k)

Tri-Staple 2.0 Reloads

N.º K: K202864 · 2020-10-28

Fecha de decisión2020-10-28

Código de productoGDW

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tri-Staple 2.0 Reloads is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K202864. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tri-Staple 2.0 Reloads?

Tri-Staple 2.0 Reloads is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Covidien. The 510(k) number is K202864.

When did Tri-Staple 2.0 Reloads receive FDA 510(k) clearance?

Tri-Staple 2.0 Reloads received FDA 510(k) clearance on 2020-10-28, under 510(k) number K202864.

Who is the listed applicant for Tri-Staple 2.0 Reloads?

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 Reloads?

The FDA product code for Tri-Staple 2.0 Reloads is GDW.

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Fuente oficial

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