Device Classification Name |
system, surgical, computer controlled instrument
|
510(k) Number |
K170879 |
Device Name |
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories |
Applicant |
Intuitive Surgical, Inc. |
1266 Kifer Road |
Building 101 |
Sunnyvale,
CA
94086
|
|
Applicant Contact |
Kunal Gunjal |
Correspondent |
Intuitive Surgical, Inc. |
1266 Kifer Road |
Building 101 |
Sunnyvale,
CA
94086
|
|
Correspondent Contact |
Kunal Gunjal |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/24/2017 |
Decision Date | 09/21/2017 |
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
|
|
|