Cleared Traditional

SD LTM STIM Cortical Stimulator

K180761 · Micromed S.P.A. · Neurology
Jun 2018
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K180761 is an FDA 510(k) clearance for the SD LTM STIM Cortical Stimulator, a Electrode, Cortical (Class II — Special Controls, product code GYC), submitted by Micromed S.P.A. (Mogliano Veneto, IT). The FDA issued a Cleared decision on June 18, 2018, 87 days after receiving the submission on March 23, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1310.

Submission Details

510(k) Number K180761 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2018
Decision Date June 18, 2018
Days to Decision 87 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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