Cleared Traditional

Avologi Gel Primer (Model: Av25)

K220735 · Premier North America, Inc. · Neurology

Sep 2023

Decision

550d

Days

Class 2

Risk

About This 510(k) Submission

K220735 is an FDA 510(k) clearance for the Avologi Gel Primer (Model: Av25), a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Premier North America, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on September 15, 2023, 550 days after receiving the submission on March 14, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number	K220735 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2022
Decision Date	September 15, 2023
Days to Decision	550 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF