Cleared Traditional

GT5 conductive & abrasive gel

K212787 · Wuhan Greentek Pty , Ltd. · Neurology
Nov 2021
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K212787 is an FDA 510(k) clearance for the GT5 conductive & abrasive gel, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Wuhan Greentek Pty , Ltd. (Wuhan, CN). The FDA issued a Cleared decision on November 8, 2021, 68 days after receiving the submission on September 1, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K212787 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2021
Decision Date November 08, 2021
Days to Decision 68 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