FDA 510(k)

POWERSEAL Sealer and Divider

N.º K: K231327 · 2023-10-25

Fecha de decisión2023-10-25

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

POWERSEAL Sealer and Divider is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K231327. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the POWERSEAL Sealer and Divider?

POWERSEAL Sealer and Divider is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K231327.

When did POWERSEAL Sealer and Divider receive FDA 510(k) clearance?

POWERSEAL Sealer and Divider received FDA 510(k) clearance on 2023-10-25, under 510(k) number K231327.

Who is the listed applicant for POWERSEAL Sealer and Divider?

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

What is the FDA product code for POWERSEAL Sealer and Divider?

The FDA product code for POWERSEAL Sealer and Divider is GEI.

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Otros registros que enlistan a Gyrus Acmi, Inc. como solicitante

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Fuente oficial

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