FDA 510(k)

Sistema de Terapia de Ferida de Pressão Negativa AVELLE

Número K: K180205 · 2018-10-19

Data da decisão2018-10-19

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AVELLE Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2018-10-19 under 510(k) number K180205. 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 AVELLE Negative Pressure Wound Therapy System?

AVELLE Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2018-10-19. The listed applicant is Convatec Limited. The 510(k) number is K180205.

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

AVELLE Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2018-10-19, under 510(k) number K180205.

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

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

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

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

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