FDA 510(k)

Invia Ease Negative Pressure Wound Therapy (NPWT) System

Número K: K214112 · 2022-07-26

Data da decisão2022-07-26

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Invia Ease Negative Pressure Wound Therapy (NPWT) System is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2022-07-26 under 510(k) number K214112. 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 Invia Ease Negative Pressure Wound Therapy (NPWT) System?

Invia Ease Negative Pressure Wound Therapy (NPWT) System is a medical device that received FDA 510(k) clearance on 2022-07-26. The listed applicant is Medela AG. The 510(k) number is K214112.

When did Invia Ease Negative Pressure Wound Therapy (NPWT) System receive FDA 510(k) clearance?

Invia Ease Negative Pressure Wound Therapy (NPWT) System received FDA 510(k) clearance on 2022-07-26, under 510(k) number K214112.

Who is the listed applicant for Invia Ease Negative Pressure Wound Therapy (NPWT) System?

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

What is the FDA product code for Invia Ease Negative Pressure Wound Therapy (NPWT) System?

The FDA product code for Invia Ease Negative Pressure Wound Therapy (NPWT) System is OMP.

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Outros registros que listam Medela AG como candidato(a)

K251377Magic InBra K223388Invia® Integrated Dressing K191653Freestyle Flex K182191Invia Abdominal Dressing Kit K180415Invia White Foam NPWT K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad

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Dispositivos Relacionados (Código: OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.

Fonte oficial

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