Cleared Traditional

Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode

K191186 · Ad-Tech Medical Instrument Corporation · Neurology
Jan 2020
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K191186 is an FDA 510(k) clearance for the Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode, a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by Ad-Tech Medical Instrument Corporation (Oak Creek, US). The FDA issued a Cleared decision on January 25, 2020, 267 days after receiving the submission on May 3, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K191186 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2019
Decision Date January 25, 2020
Days to Decision 267 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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