Device Classification Name |
staple, implantable
|
510(k) Number |
K172361 |
Device Name |
EEA Circular Stapler with Tri-Staple Technology |
Applicant |
Covidien |
Rooms 501, 502, 601, 602 No.3 building |
No.2388, Chen Hang Road |
Min Hang District, Shanghai,
CN
201114
|
|
Applicant Contact |
Sarah Tang |
Correspondent |
Covidien |
Rooms 501, 502, 601, 602 No.3 building |
No.2388, Chen Hang Road |
Min Hang District, Shanghai,
CN
201114
|
|
Correspondent Contact |
Sarah Tang |
Regulation Number | 878.4750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/04/2017 |
Decision Date | 02/16/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|