Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K133845 |
Device Name |
8MM TROCAR KIT |
Applicant |
INTUITIVE SURGICAL |
1266 KIFER ROAD |
SUNNYVALE,
CA
94086
|
|
Applicant Contact |
BRANDON HANSEN |
Correspondent |
INTUITIVE SURGICAL |
1266 KIFER ROAD |
SUNNYVALE,
CA
94086
|
|
Correspondent Contact |
BRANDON HANSEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/18/2013 |
Decision Date | 02/19/2014 |
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
|
|
|