STAR RF Ablation System
FDA 510(k) K251802 · Merit Medical Systems, Inc.
510(k) numberK251802
Submission
- Device name
- STAR RF Ablation System
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- June 12, 2025
- Decision date
- February 13, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was STAR RF Ablation System cleared by the FDA?
STAR RF Ablation System (K251802) received a 510(k) decision of Substantially Equivalent on February 13, 2026, 246 days after the submission was received.
What is the product code of K251802?
The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.