Cleared Traditional

STAR RF Ablation System

K251802 · Merit Medical Systems, Inc. · Neurology
Feb 2026
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K251802 is an FDA 510(k) clearance for the STAR RF Ablation System, a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 13, 2026, 246 days after receiving the submission on June 12, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4725.

Submission Details

510(k) Number K251802 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2025
Decision Date February 13, 2026
Days to Decision 246 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXI — Probe, Radiofrequency Lesion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4725

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