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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Surgical, Computer Controlled Instrument
510(k) Number K240502
Device Name da Vinci SP Surgical System (SP1098)
Applicant
Intuitive Surgical, Inc.
1020 Kifer Rd.
Sunnyvale,  CA  94086
Applicant Contact Mike Yramategui
Correspondent
Intuitive Surgical, Inc.
1020 Kifer Rd.
Sunnyvale,  CA  94086
Correspondent Contact Mike Yramategui
Regulation Number876.1500
Classification Product Code
NAY  
Date Received02/21/2024
Decision Date 07/08/2024
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT05150210
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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