FDA 510(k)

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini

Número K: K170381 · 2017-09-07

Data da decisão2017-09-07

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini 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 2017-09-07 under 510(k) number K170381. 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 Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini?

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K170381.

When did Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini receive FDA 510(k) clearance?

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini received FDA 510(k) clearance on 2017-09-07, under 510(k) number K170381.

Who is the listed applicant for Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini?

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 Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini?

The FDA product code for Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini is GEI.

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