STAR RF Ablation System
by Merit Medical Systems, Inc.
510(k) K251802
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Overview
A comprehensive guide to the STAR RF Ablation System, including its features, compliance, and regulatory status.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251802 | Date13 Feb 2026 | StatusActive |
Official records
- FDA 510(k) database K251802
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GXI
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4725
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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