Cleared Traditional

Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid

K211954 · Spes Medica Srl · Neurology
Nov 2022
Decision
505d
Days
Class 2
Risk

About This 510(k) Submission

K211954 is an FDA 510(k) clearance for the Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid, a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by Spes Medica Srl (Battipaglia, IT). The FDA issued a Cleared decision on November 10, 2022, 505 days after receiving the submission on June 23, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K211954 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2021
Decision Date November 10, 2022
Days to Decision 505 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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