FDA 510(k)

extriCARE 1000 Negative Pressure Wound Therapy System

Número K: K213906 · 2023-03-08

Data da decisão2023-03-08

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

extriCARE 1000 Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Alleva Medical, Ltd.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K213906. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the extriCARE 1000 Negative Pressure Wound Therapy System?

extriCARE 1000 Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Alleva Medical, Ltd.. The 510(k) number is K213906.

When did extriCARE 1000 Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

extriCARE 1000 Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2023-03-08, under 510(k) number K213906.

Who is the listed applicant for extriCARE 1000 Negative Pressure Wound Therapy System?

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

What is the FDA product code for extriCARE 1000 Negative Pressure Wound Therapy System?

The FDA product code for extriCARE 1000 Negative Pressure Wound Therapy System is OMP.

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