FDA 510(k)

PK Morcellator

Número K: K161038 · 2016-10-07

Data da decisão2016-10-07

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PK Morcellator 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 2016-10-07 under 510(k) number K161038. 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 PK Morcellator?

PK Morcellator is a medical device that received FDA 510(k) clearance on 2016-10-07. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K161038.

When did PK Morcellator receive FDA 510(k) clearance?

PK Morcellator received FDA 510(k) clearance on 2016-10-07, under 510(k) number K161038.

Who is the listed applicant for PK Morcellator?

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 PK Morcellator?

The FDA product code for PK Morcellator is GEI.

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Fonte oficial

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