FDA 510(k)

gi-4000 Electrosurgical Generator

Número K: K172805 · 2017-10-23

RequerenteUnited States Endoscopy Group, Inc.

Data da decisão2017-10-23

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do 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 2017-10-23 under 510(k) number K172805. 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 gi-4000 Electrosurgical Generator?

gi-4000 Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K172805.

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

gi-4000 Electrosurgical Generator received FDA 510(k) clearance on 2017-10-23, under 510(k) number K172805.

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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Fonte oficial

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