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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 K214058
Device Name Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact Kavita Amin
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact Kavita Amin
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/27/2021
Decision Date 08/26/2022
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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