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FDA 510(k)

Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA

N.º K: K221003 · 2022-09-30

SolicitanteCovidien
Fecha de decisión2022-09-30
Código de productoGDW
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K221003. 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 Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA?

Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Covidien. The 510(k) number is K221003.

When did Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA receive FDA 510(k) clearance?

Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA received FDA 510(k) clearance on 2022-09-30, under 510(k) number K221003.

Who is the listed applicant for Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA?

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 Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA?

The FDA product code for Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA is GDW.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

Otros registros que enlistan a Covidien como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Dispositivos relacionados (Código: GDW)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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