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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K262455
Device Name da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  94086
Applicant Contact Diana Gutierrez Franco
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  94086
Correspondent Contact Diana Gutierrez Franco
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
IZI   KCT   NAY  
Date Received07/17/2026
Decision Date 10/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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