FDA 510(k)

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11

Número K: K200841 · 2020-05-11

Data da decisão2020-05-11

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2020-05-11 under 510(k) number K200841. 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 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11?

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 is a medical device that received FDA 510(k) clearance on 2020-05-11. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K200841.

When did Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 receive FDA 510(k) clearance?

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 received FDA 510(k) clearance on 2020-05-11, under 510(k) number K200841.

Who is the listed applicant for Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11?

The FDA 510(k) record lists Ethicon Endo-Surgery, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11?

The FDA product code for Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 is GEI.

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Fonte oficial

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