FDA 510(k)

Aplicador Electrosurgical de Tratamento Endoscópico com Agulha Ativa (ANET)

Número K: K170990 · 2017-05-11

Data da decisão2017-05-11

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Spiration, Inc.. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K170990. 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 Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator?

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Spiration, Inc.. The 510(k) number is K170990.

When did Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator receive FDA 510(k) clearance?

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator received FDA 510(k) clearance on 2017-05-11, under 510(k) number K170990.

Who is the listed applicant for Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator?

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

What is the FDA product code for Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator?

The FDA product code for Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator is GEI.

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Fonte oficial

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