Device Classification Name |
system, surgical, computer controlled instrument
|
510(k) Number |
K150837 |
Device Name |
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps |
Applicant |
INTUITIVE SURGICAL, INC. |
1266 KIFER ROAD |
SUNNYVALE,
CA
94086
|
|
Applicant Contact |
SARAH RIZK |
Correspondent |
INTUITIVE SURGICAL, INC. |
1266 KIFER ROAD |
SUNNYVALE,
CA
94086
|
|
Correspondent Contact |
SARAH RIZK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/30/2015 |
Decision Date | 04/29/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|