STAR RF Ablation System— 510(k) K251802
Substantially EquivalentMerit 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.
Summary
Merit Medical Systems' STAR RF Ablation System is filed under product code GXI, radiofrequency lesion probe. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 882.4725. Neurology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Merit Medical Systems filed from South Jordan, Utah. Review took 246 calendar days (June 12, 2025 to February 13, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Product code GXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.4725
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
Recent devices under product code GXI
view allMore clearances from Merit Medical Systems, Inc.
view allAdverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
Source: openFDA MAUDE database, through . 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.