Device Classification Name |
system, surgical, computer controlled instrument
|
510(k) Number |
K002489 |
Device Name |
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM |
Applicant |
INTUITIVE SURGICAL, INC. |
1340 WEST MIDDLEFIELD RD. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
DAVID CASAL |
Correspondent |
INTUITIVE SURGICAL, INC. |
1340 WEST MIDDLEFIELD RD. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
DAVID CASAL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/10/2000 |
Decision Date | 03/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|