IonicRF Generator— 510(k) K201610

Name: FDA 510(k) clearance K201610
Creator: U.S. Food and Drug Administration
Published: 2020-10-21

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K201610 for IonicRF Generator, Substantially Equivalent on 2020-10-21. Applicant: ABBOTT MEDICAL. Device class: 2.

Clearance details

Applicant: ABBOTT MEDICAL
Product code: Code GXD
Device class: Class 2
Regulation: 21 CFR 882.4400
Advisory panel: Neurology
Date received: 2020-06-15
Decision date: 2020-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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K231675 — OneRF Ablation System2023-12-06
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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.