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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical, Active, Urological
510(k) Number K213135
Device Name Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
Applicant
Chirurgie Innovation
Z.A Les Godets, 3 Rue Des Petits Ruisseaux
Verrières Le Buisson,  FR 91370
Applicant Contact Guillaume Noury
Correspondent
Chirurgie Innovation
Z.A Les Godets, 3 Rue Des Petits Ruisseaux
Verrières Le Buisson,  FR 91370
Correspondent Contact Guillaume Noury
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Codes
FDC   GEI  
Date Received09/27/2021
Decision Date 03/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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