Cleared Traditional

OneRF Ablation System

K231675 · Neuroone Medical Technologies Corp. · Neurology
Dec 2023
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K231675 is an FDA 510(k) clearance for the OneRF Ablation System, a Generator, Lesion, Radiofrequency (Class II — Special Controls, product code GXD), submitted by Neuroone Medical Technologies Corp. (Eden Prairie, US). The FDA issued a Cleared decision on December 6, 2023, 181 days after receiving the submission on June 8, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4400.

Submission Details

510(k) Number K231675 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2023
Decision Date December 06, 2023
Days to Decision 181 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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