Cleared Traditional

APEX 6

K220122 · Rf Innovations, Inc. · Neurology
Mar 2023
Decision
421d
Days
Class 2
Risk

About This 510(k) Submission

K220122 is an FDA 510(k) clearance for the APEX 6, a Generator, Lesion, Radiofrequency (Class II — Special Controls, product code GXD), submitted by Rf Innovations, Inc. (Middleton, US). The FDA issued a Cleared decision on March 15, 2023, 421 days after receiving the submission on January 18, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4400.

Submission Details

510(k) Number K220122 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2022
Decision Date March 15, 2023
Days to Decision 421 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXD — Generator, Lesion, Radiofrequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4400

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