FDA 510(k)

IRRIGO Wound Wash Jet System

Número K: K210987 · 2022-05-31

Data da decisão2022-05-31

Código do produtoFQH

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

IRRIGO Wound Wash Jet System is the device name listed in this FDA 510(k) record. The listed applicant is Inopro, Inc.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K210987. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IRRIGO Wound Wash Jet System?

IRRIGO Wound Wash Jet System is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Inopro, Inc.. The 510(k) number is K210987.

When did IRRIGO Wound Wash Jet System receive FDA 510(k) clearance?

IRRIGO Wound Wash Jet System received FDA 510(k) clearance on 2022-05-31, under 510(k) number K210987.

Who is the listed applicant for IRRIGO Wound Wash Jet System?

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

What is the FDA product code for IRRIGO Wound Wash Jet System?

The FDA product code for IRRIGO Wound Wash Jet System is FQH.

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