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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 K223039
Device Name da Vinci E-200 Electrosurgical Generator
Applicant
Intuitive Surgical
1266 Kifer Rd.
Sunnyvale,  CA  94086
Applicant Contact Shamsa Karimi
Correspondent
Intuitive Surgical
1266 Kifer Rd.
Sunnyvale,  CA  94086
Correspondent Contact Shamsa Karimi
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/29/2022
Decision Date 11/28/2022
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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