Device Classification Name |
System, Surgical, Computer Controlled Instrument
|
510(k) Number |
K173721 |
Device Name |
SureForm 60 and SureForm 60 Reloads |
Applicant |
Intuitive Surgical |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Applicant Contact |
Nadine Nasr |
Correspondent |
Intuitive Surgical |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Correspondent Contact |
Nadine Nasr |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/05/2017 |
Decision Date | 07/05/2018 |
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
|
Recalls |
CDRH Recalls
|