Device Classification Name |
system, surgical, computer controlled instrument
|
510(k) Number |
K191529 |
Device Name |
da Vinci Xi Surgical System, da Vinci X Surgical System |
Applicant |
Intuitive Surgical |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Applicant Contact |
Brandon Hansen |
Correspondent |
Intuitive Surgical |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Correspondent Contact |
Brandon Hansen |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/10/2019 |
Decision Date | 02/06/2020 |
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
|
|
|