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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 K192128
Device Name Sutter Arrowtip Monopolar Electrodes
Applicant
Sutter Medizintechnik GmbH
Tullastrasse 87
Freiburg,  DE 79108
Applicant Contact Ulrike Zeissler
Correspondent
Sutter Medizintechnik GmbH
Tullastrasse 87
Freiburg,  DE 79108
Correspondent Contact Ulrike Zeissler
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/07/2019
Decision Date 10/04/2019
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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