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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 K261179
Device Name AlphaTriPart - Monopolar MIC Instruments
Applicant
Gimmi GmbH
Carl-Zeiss-Str. 6
Tuttlingen,  DE 78532
Applicant Contact Anita Rudischhauser
Correspondent
Gimmi GmbH
Carl-Zeiss-Str. 6
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Tuttlingen,  DE 78532
Correspondent Contact Nicolas Geisheimer
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/10/2026
Decision Date 07/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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