FDA 510(k)

SURGIPHOR Wound Irrigation System

Número K: K202071 · 2020-10-23

Data da decisão2020-10-23

Código do produtoFQH

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SURGIPHOR Wound Irrigation System is the device name listed in this FDA 510(k) record. The listed applicant is Orthophor, LLC. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K202071. 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 SURGIPHOR Wound Irrigation System?

SURGIPHOR Wound Irrigation System is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Orthophor, LLC. The 510(k) number is K202071.

When did SURGIPHOR Wound Irrigation System receive FDA 510(k) clearance?

SURGIPHOR Wound Irrigation System received FDA 510(k) clearance on 2020-10-23, under 510(k) number K202071.

Who is the listed applicant for SURGIPHOR Wound Irrigation System?

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

What is the FDA product code for SURGIPHOR Wound Irrigation System?

The FDA product code for SURGIPHOR Wound Irrigation System is FQH.

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