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FDA 510(k)

WISE Cortical Strip (WCS)

K-Number: K221123 · 2022-11-22

ApplicantWise S.R.L.
Decision Date2022-11-22
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Wise S.R.L.. The 510(k) number is K221123.

When was WISE Cortical Strip (WCS) approved by the FDA?

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

What company makes WISE Cortical Strip (WCS)?

WISE Cortical Strip (WCS) is manufactured by Wise S.R.L..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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