Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K120403 |
Device Name |
SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER |
Applicant |
TRANSENTERIX, INC. |
635 DAVIS DRIVE SUITE 300 |
DURHAM,
NC
27560
|
|
Applicant Contact |
TAMMY B CARREA |
Correspondent |
TRANSENTERIX, INC. |
635 DAVIS DRIVE SUITE 300 |
DURHAM,
NC
27560
|
|
Correspondent Contact |
TAMMY B CARREA |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/09/2012 |
Decision Date | 04/16/2012 |
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
|
|
|