FDA 510(k)

gi-4000 Electrosurgical Generator

N.º K: K192265 · 2020-05-21

SolicitanteUnited States Endoscopy Group, Inc.

Fecha de decisión2020-05-21

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

gi-4000 Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K192265. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the gi-4000 Electrosurgical Generator?

gi-4000 Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K192265.

When did gi-4000 Electrosurgical Generator receive FDA 510(k) clearance?

gi-4000 Electrosurgical Generator received FDA 510(k) clearance on 2020-05-21, under 510(k) number K192265.

Who is the listed applicant for gi-4000 Electrosurgical Generator?

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

What is the FDA product code for gi-4000 Electrosurgical Generator?

The FDA product code for gi-4000 Electrosurgical Generator is GEI.

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Fuente oficial

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