FDA 510(k)

FMS VUE™ Fluid Management and Tissue Debridement System

Número K: K233675 · 2024-02-26

Data da decisão2024-02-26

Código do produtoHRX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FMS VUE™ Fluid Management and Tissue Debridement System is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Mitek, Inc.. It received FDA 510(k) clearance on 2024-02-26 under 510(k) number K233675. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FMS VUE™ Fluid Management and Tissue Debridement System?

FMS VUE™ Fluid Management and Tissue Debridement System is a medical device that received FDA 510(k) clearance on 2024-02-26. The listed applicant is DePuy Mitek, Inc.. The 510(k) number is K233675.

When did FMS VUE™ Fluid Management and Tissue Debridement System receive FDA 510(k) clearance?

FMS VUE™ Fluid Management and Tissue Debridement System received FDA 510(k) clearance on 2024-02-26, under 510(k) number K233675.

Who is the listed applicant for FMS VUE™ Fluid Management and Tissue Debridement System?

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

What is the FDA product code for FMS VUE™ Fluid Management and Tissue Debridement System?

The FDA product code for FMS VUE™ Fluid Management and Tissue Debridement System is HRX.

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