Device Classification Name |
System, Surgical, Computer Controlled Instrument
|
510(k) Number |
K131962 |
Device Name |
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES |
Applicant |
INTUITIVE SURGICAL, INC. |
1266 KIFER ROAD |
SUNNYVALE,
CA
94086
|
|
Applicant Contact |
MIKE YRAMATEGUI |
Correspondent |
INTUITIVE SURGICAL, INC. |
1266 KIFER ROAD |
SUNNYVALE,
CA
94086
|
|
Correspondent Contact |
MIKE YRAMATEGUI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/27/2013 |
Decision Date | 04/17/2014 |
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
|
|
|