Disposable Radiofrequency Cannula— 510(k) K253907

Name: FDA 510(k) clearance K253907
Creator: U.S. Food and Drug Administration
Published: 2026-04-16

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K253907 for Disposable Radiofrequency Cannula, Substantially Equivalent on 2026-04-16. Applicant: ABBOTT MEDICAL. Device class: 2.

Clearance details

Applicant: ABBOTT MEDICAL
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 2025-12-05
Decision date: 2026-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXI

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K251802 — STAR RF Ablation System2026-02-13
K251243 — OneRF Trigeminal Nerve Radiofrequency Probes2025-08-15
K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)2025-05-27
K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more2025-05-15
K241367 — RF Cannula2025-01-23

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K253459 — OPTIS Mobile Next Imaging System (1014932) +2 more2026-04-24
K260212 — EnSite X EP System2026-04-20
K260499 — Amplatzer Trevisio Intravascular Delivery System +1 more2026-03-13

Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

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.