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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K253915
Device Name MOVIVA® Hybrid Ablation Probe
Applicant
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
Tuebingen,  DE 72072
Applicant Contact Matthias Kollek
Correspondent
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
Tuebingen,  DE 72072
Correspondent Contact Matthias Kollek
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
FQH  
Date Received12/08/2025
Decision Date 12/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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