FDA 510(k)

PWD Negative Pressure Wound Therapy System

Número K: K212359 · 2022-09-21

RequerenteApplied Tissue Technologies, LLC

Data da decisão2022-09-21

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

PWD Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Tissue Technologies, LLC. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K212359. 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 PWD Negative Pressure Wound Therapy System?

PWD Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Applied Tissue Technologies, LLC. The 510(k) number is K212359.

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

PWD Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2022-09-21, under 510(k) number K212359.

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

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

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

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

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