Cleared Traditional

K221123 - WISE Cortical Strip (WCS)
(FDA 510(k) Clearance)

K221123 · Wise S.R.L. · Neurology
Nov 2022
Decision
218d
Days
Class 2
Risk

K221123 is an FDA 510(k) clearance for the WISE Cortical Strip (WCS), a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by Wise S.R.L. (Cologno Monzese, IT). The FDA issued a Cleared decision on November 22, 2022, 218 days after receiving the submission on April 18, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K221123 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2022
Decision Date November 22, 2022
Days to Decision 218 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GYC — Electrode, Cortical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1310

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