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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stapler, Surgical
510(k) Number K243596
Device Name da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
Applicant
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Alifiya Jagmag
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale,  CA  94086
Correspondent Contact Alifiya Jagmag
Regulation Number878.4740
Classification Product Code
GAG  
Subsequent Product Codes
GDW   NAY  
Date Received11/21/2024
Decision Date 03/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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