FDA 510(k)

MOVIVA® Hybrid Ablation Probe

Número K: K253915 · 2025-12-18

Data da decisão2025-12-18

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

MOVIVA® Hybrid Ablation Probe is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K253915. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MOVIVA® Hybrid Ablation Probe?

MOVIVA® Hybrid Ablation Probe is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K253915.

When did MOVIVA® Hybrid Ablation Probe receive FDA 510(k) clearance?

MOVIVA® Hybrid Ablation Probe received FDA 510(k) clearance on 2025-12-18, under 510(k) number K253915.

Who is the listed applicant for MOVIVA® Hybrid Ablation Probe?

The FDA 510(k) record lists Erbe Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOVIVA® Hybrid Ablation Probe?

The FDA product code for MOVIVA® Hybrid Ablation Probe is GEI.

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Fonte oficial

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