FDA 510(k)

PlasmaBlade T

Número K: K170610 · 2017-04-13

Data da decisão2017-04-13

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PlasmaBlade T is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Advanced Energy. It received FDA 510(k) clearance on 2017-04-13 under 510(k) number K170610. 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 PlasmaBlade T?

PlasmaBlade T is a medical device that received FDA 510(k) clearance on 2017-04-13. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K170610.

When did PlasmaBlade T receive FDA 510(k) clearance?

PlasmaBlade T received FDA 510(k) clearance on 2017-04-13, under 510(k) number K170610.

Who is the listed applicant for PlasmaBlade T?

The FDA 510(k) record lists Medtronic Advanced Energy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PlasmaBlade T?

The FDA product code for PlasmaBlade T is GEI.

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Outros registros que listam Medtronic Advanced Energy como candidato(a)

K183129Medtronic Total Hip Arthroplasty System K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0 K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini K170296CoreCath 2.7S K152703PlasmaBlade TnA Tonsil and Adenoid Dissection Device

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Fonte oficial

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