Device Classification Name |
System, Surgical, Computer Controlled Instrument
|
510(k) Number |
K171120 |
Device Name |
Senhance Surgical Robotic System |
Applicant |
TransEnterix, Inc. |
635 Davis Drive, Suite 300 |
Morrisville,
NC
27560
|
|
Applicant Contact |
Stephanie Fitts |
Correspondent |
TransEnterix, Inc. |
635 Davis Drive, Suite 300 |
Morrisville,
NC
27560
|
|
Correspondent Contact |
Stephanie Fitts |
Regulation Number | 876.1500 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/14/2017 |
Decision Date | 10/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT03093675
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|