K251802
- 510(k) number
- K251802
- Device name
- STAR RF Ablation System
- Applicant
- Merit Medical Systems, Inc. UT · US
- Product code
- GXI — Probe, Radiofrequency Lesion
- Decision date
- 2026-02-13
- Date received
- 2025-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251802.pdf
Official FDA record: K251802
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.