FDA 510(k)

gi2000 Electrosurgical Generator

Número K: K250657 · 2025-06-03

Data da decisão2025-06-03

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

gi2000 Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Cintron Medical Corporation. It received FDA 510(k) clearance on 2025-06-03 under 510(k) number K250657. 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 gi2000 Electrosurgical Generator?

gi2000 Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2025-06-03. The listed applicant is Cintron Medical Corporation. The 510(k) number is K250657.

When did gi2000 Electrosurgical Generator receive FDA 510(k) clearance?

gi2000 Electrosurgical Generator received FDA 510(k) clearance on 2025-06-03, under 510(k) number K250657.

Who is the listed applicant for gi2000 Electrosurgical Generator?

The FDA 510(k) record lists Cintron Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for gi2000 Electrosurgical Generator?

The FDA product code for gi2000 Electrosurgical Generator is GEI.

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