FDA 510(k)

ConvaVAC™ Negative Pressure Wound Therapy System

Número K: K253263 · 2026-06-24

RequerenteConvatec Limited, Gdc Building

Data da decisão2026-06-24

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ConvaVAC™ Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited, Gdc Building. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K253263. 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 ConvaVAC™ Negative Pressure Wound Therapy System?

ConvaVAC™ Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Convatec Limited, Gdc Building. The 510(k) number is K253263.

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

ConvaVAC™ Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2026-06-24, under 510(k) number K253263.

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

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

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

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

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