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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 K222839
FOIA Releasable 510(k) K222839
Device Name EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  94086
Applicant Contact Amrit Jaggi
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
Sunnyvale,  CA  94086
Correspondent Contact Amrit Jaggi
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Codes
GAG   GDW  
Date Received09/20/2022
Decision Date 03/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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