FDA 510(k)

WISE Cortical Strip (WCS)

Número K: K221123 · 2022-11-22

Data da decisão2022-11-22

Código do produtoGYC

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

WISE Cortical Strip (WCS) is the device name listed in this FDA 510(k) record. The listed applicant is Wise S.R.L.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K221123. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WISE Cortical Strip (WCS)?

WISE Cortical Strip (WCS) is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Wise S.R.L.. The 510(k) number is K221123.

When did WISE Cortical Strip (WCS) receive FDA 510(k) clearance?

WISE Cortical Strip (WCS) received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221123.

Who is the listed applicant for WISE Cortical Strip (WCS)?

The FDA 510(k) record lists Wise S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WISE Cortical Strip (WCS)?

The FDA product code for WISE Cortical Strip (WCS) is GYC.

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