Device Classification Name |
system, surgical, computer controlled instrument
|
510(k) Number |
K143132 |
Device Name |
IS4000 8mm Harmonic ACE Curved Shears |
Applicant |
INTUITIVE SURGICAL, INC. |
1266 KIFER ROAD |
SUNNYVALE,
CA
94086 -5206
|
|
Applicant Contact |
EARLE CANTY |
Correspondent |
INTUITIVE SURGICAL, INC. |
1266 KIFER ROAD |
SUNNYVALE,
CA
94086 -5206
|
|
Correspondent Contact |
NADINE NASR |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/31/2014 |
Decision Date | 04/02/2015 |
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
|
|
|