STAR RF Ablation System— 510(k) K251802

Name: FDA 510(k) clearance K251802
Creator: U.S. Food and Drug Administration
Published: 2026-02-13

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K251802 for STAR RF Ablation System, Substantially Equivalent on 2026-02-13. Applicant: Merit Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 2025-06-12
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXI

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K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more2025-05-15
K241367 — RF Cannula2025-01-23

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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.