K251802
Substantially EquivalentSTAR RF Ablation System
- Applicant
- Merit Medical Systems, Inc.
- Product code
- GXI
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
Adverse 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.