Device Classification Name |
System, Surgical, Computer Controlled Instrument
|
510(k) Number |
K203632 |
Device Name |
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments |
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 |
|
Subsequent Product Code |
|
Date Received | 12/11/2020 |
Decision Date | 02/10/2021 |
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
|
|
|