OneRF Ablation System— 510(k) K231675

Name: FDA 510(k) clearance K231675
Creator: U.S. Food and Drug Administration
Published: 2023-12-06

Substantially Equivalent

Neuroone Medical Technologies Corp.

FDA 510(k) clearance K231675 for OneRF Ablation System, Substantially Equivalent on 2023-12-06. Applicant: Neuroone Medical Technologies Corp.. Device class: 2.

Clearance details

Applicant: Neuroone Medical Technologies Corp.
Product code: Code GXD
Device class: Class 2
Regulation: 21 CFR 882.4400
Advisory panel: Neurology
Date received: 2023-06-08
Decision date: 2023-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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K211367 — Evo sEEG System2021-09-01

Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.