FDA 510(k)

VacHeal Negative Pressure Wound Therapy System

Número K: K254160 · 2026-09-18

Data da decisão2026-09-18

Código do produtoOKO

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

VacHeal Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is VacHeal, LLC. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K254160. The device is classified under product code OKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VacHeal Negative Pressure Wound Therapy System?

VacHeal Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is VacHeal, LLC. The 510(k) number is K254160.

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

VacHeal Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2026-09-18, under 510(k) number K254160.

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

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

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

The FDA product code for VacHeal Negative Pressure Wound Therapy System is OKO.

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