FDA 510(k)

INTELLIO SHIFT System

Número K: K232290 · 2023-12-11

Data da decisão2023-12-11

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

INTELLIO SHIFT System is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2023-12-11 under 510(k) number K232290. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the INTELLIO SHIFT System?

INTELLIO SHIFT System is a medical device that received FDA 510(k) clearance on 2023-12-11. The listed applicant is ArthroCare Corporation. The 510(k) number is K232290.

When did INTELLIO SHIFT System receive FDA 510(k) clearance?

INTELLIO SHIFT System received FDA 510(k) clearance on 2023-12-11, under 510(k) number K232290.

Who is the listed applicant for INTELLIO SHIFT System?

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

What is the FDA product code for INTELLIO SHIFT System?

The FDA product code for INTELLIO SHIFT System is GEI.

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