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FDA 510(k)

MOVIVA® Hybrid Ablation Probe

K-Number: K253915 · 2025-12-18

ApplicantErbe Elektromedizin GmbH
Decision Date2025-12-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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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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