Device Classification Name |
System, Surgical, Computer Controlled Instrument
|
510(k) Number |
K211997 |
Device Name |
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads |
Applicant |
Intuitive Surgical, Inc. |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Applicant Contact |
Amrit Jaggi |
Correspondent |
Intuitive Surgical, Inc. |
1266 Kifer Road |
Sunnyvale,
CA
94086
|
|
Correspondent Contact |
Amrit Jaggi |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/28/2021 |
Decision Date | 12/10/2021 |
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
|
Recalls |
CDRH Recalls
|
|
|