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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 K133203
Device Name SINGLE-SITE PORT
Applicant
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BLDG. 101
SUNNYVALE,  CA  94086 -5206
Applicant Contact EINAV YEMINI
Correspondent
INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BLDG. 101
SUNNYVALE,  CA  94086 -5206
Correspondent Contact EINAV YEMINI
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
NAY  
Date Received10/17/2013
Decision Date 05/09/2014
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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