FDA 510(k)

EEA Circular Stapler with Tri-Staple Technology

N.º K: K202507 · 2021-01-21

Fecha de decisión2021-01-21

Código de productoGDW

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del 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 2021-01-21 under 510(k) number K202507. 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 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 2021-01-21. The listed applicant is Covidien. The 510(k) number is K202507.

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 2021-01-21, under 510(k) number K202507.

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)

Fuente oficial

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