FDA 510(k)

STAR RF Ablation System

Número K: K251802 · 2026-02-13

Data da decisão2026-02-13

Código do produtoGXI

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K251802.

When did STAR RF Ablation System receive FDA 510(k) clearance?

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

Who is the listed applicant for STAR RF Ablation System?

The FDA 510(k) record lists Merit Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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