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FDA 510(k)

STAR RF Ablation System

K-Number: K251802 · 2026-02-13

ApplicantMerit Medical Systems, Inc.
Decision Date2026-02-13
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STAR RF Ablation System is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-02-13 under approval number K251802. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAR RF Ablation System?

STAR RF Ablation System is a medical device that received FDA 510(k) clearance on 2026-02-13. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K251802.

When was STAR RF Ablation System approved by the FDA?

STAR RF Ablation System received FDA 510(k) clearance on 2026-02-13, under approval number K251802.

What company makes STAR RF Ablation System?

STAR RF Ablation System is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for STAR RF Ablation System?

The FDA product code for STAR RF Ablation System is GXI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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