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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 K120215
Device Name SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE
Applicant
INTUITIVE SURGICAL, INC.
1450 Kifer Rd
--
Sunnyvale,  CA  94086
Applicant Contact KIM T SERVANCE
Correspondent
INTUITIVE SURGICAL, INC.
1450 Kifer Rd
--
Sunnyvale,  CA  94086
Correspondent Contact KIM T SERVANCE
Regulation Number876.1500
Classification Product Code
NAY  
Subsequent Product Code
GCJ  
Date Received01/24/2012
Decision Date 04/30/2012
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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