FDA 510(k)

Controlador P8400 para o Sistema de Escalpelamento Térmico Hemostatix C2DX

Número K: K233185 · 2023-10-24

Data da decisão2023-10-24

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is the device name listed in this FDA 510(k) record. The listed applicant is C2dx, Inc.. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K233185. 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 MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is C2dx, Inc.. The 510(k) number is K233185.

When did MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System receive FDA 510(k) clearance?

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System received FDA 510(k) clearance on 2023-10-24, under 510(k) number K233185.

Who is the listed applicant for MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

The FDA 510(k) record lists C2dx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

The FDA product code for MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is GEI.

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