Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K190592 |
Device Name |
YelloPort Elite Port Access System |
Applicant |
Surgical Innovations Limited |
Clayton Wood House |
6 Clayton Wood Bank |
Leeds,
GB
LS16 6QZ
|
|
Applicant Contact |
Shazia Chaudhry |
Correspondent |
Surgical Innovations Limited |
Clayton Wood House |
6 Clayton Wood Bank |
Leeds,
GB
LS16 6QZ
|
|
Correspondent Contact |
Shazia Chaudhry |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/07/2019 |
Decision Date | 04/29/2019 |
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
|