FDA 510(k)

Iovera System

Número K: K211334 · 2021-09-10

Data da decisão2021-09-10

Código do produtoGXH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Iovera System is the device name listed in this FDA 510(k) record. The listed applicant is Pacira Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K211334. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Iovera System?

Iovera System is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Pacira Pharmaceuticals, Inc.. The 510(k) number is K211334.

When did Iovera System receive FDA 510(k) clearance?

Iovera System received FDA 510(k) clearance on 2021-09-10, under 510(k) number K211334.

Who is the listed applicant for Iovera System?

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

What is the FDA product code for Iovera System?

The FDA product code for Iovera System is GXH.

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