FDA 510(k)

POWERSEAL Sealer and Divider

Número K: K231327 · 2023-10-25

Data da decisão2023-10-25

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Gyrus Acmi, Inc. como candidato(a)

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