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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 K233425
Device Name FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)
Applicant
Sutter Medizintechnik GmbH
Alfred-Walz-Str. 22
Emmendingen,  DE 79312
Applicant Contact Simone Peschl
Correspondent
Visamed GmbH
Kastellstr.8
Karlsruhe,  DE 76227
Correspondent Contact Arne Briest
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/11/2023
Decision Date 01/25/2024
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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