Device Classification Name |
system, surgical, computer controlled instrument
|
510(k) Number |
K153276 |
Device Name |
da Vinci Xi Surgical System |
Applicant |
INTUITIVE SURGICAL, INC. |
1266 KIFER ROAD |
SUNNYVALE,
CA
94086
|
|
Applicant Contact |
Brandon Hansen |
Correspondent |
DOMECUS CONSULTING SERVICES, LLC |
1171 BARROILHET DRIVE |
HILLSBOROUGH,
CA
94010
|
|
Correspondent Contact |
Cindy Domecus |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/12/2015 |
Decision Date | 08/07/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|