Cleared Traditional

AC Cream - Conductive paste

K212326 · Spes Medica Srl · Neurology
Dec 2021
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K212326 is an FDA 510(k) clearance for the AC Cream - Conductive paste, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Spes Medica Srl (Battipaglia, IT). The FDA issued a Cleared decision on December 1, 2021, 128 days after receiving the submission on July 26, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K212326 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2021
Decision Date December 01, 2021
Days to Decision 128 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GYB — Media, Electroconductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1275