FDA 510(k)

Reprocessed Vessel Sealer

Número K: K152134 · 2016-01-15

Data da decisão2016-01-15

Código do produtoNUJ

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocessed Vessel Sealer is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K152134. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reprocessed Vessel Sealer?

Reprocessed Vessel Sealer is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Sterilmed, Inc.. The 510(k) number is K152134.

When did Reprocessed Vessel Sealer receive FDA 510(k) clearance?

Reprocessed Vessel Sealer received FDA 510(k) clearance on 2016-01-15, under 510(k) number K152134.

Who is the listed applicant for Reprocessed Vessel Sealer?

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

What is the FDA product code for Reprocessed Vessel Sealer?

The FDA product code for Reprocessed Vessel Sealer is NUJ.

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Dispositivos Relacionados (Código: NUJ)

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Fonte oficial

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