Device Classification Name |
system, surgical, computer controlled instrument
|
510(k) Number |
K232610 |
Device Name |
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation |
Applicant |
Intuitive Surgical, Inc. |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Applicant Contact |
Melissa S Gonzalez |
Correspondent |
Intuitive Surgical, Inc. |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Correspondent Contact |
Melissa S Gonzalez |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/28/2023 |
Decision Date | 03/14/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT05682742
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|