FDA 510(k)

UNO Negative Pressure Wound Therapy System

Número K: K221891 · 2022-12-14

RequerenteGenadyne Biotechnologies, Inc.

Data da decisão2022-12-14

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

UNO Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2022-12-14 under 510(k) number K221891. 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 UNO Negative Pressure Wound Therapy System?

UNO Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2022-12-14. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K221891.

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

UNO Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2022-12-14, under 510(k) number K221891.

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

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

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

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

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Outros registros que listam Genadyne Biotechnologies, Inc. como candidato(a)

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Fonte oficial

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