Device Classification Name |
Staple, Implantable
|
510(k) Number |
K162710 |
Device Name |
Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload |
Applicant |
TGS Medical Co., Ltd. |
Building 17, No.8 Jinfeng Road, High-tech Zone |
Suzhou,
CN
214163
|
|
Applicant Contact |
Hua Cao |
Correspondent |
Mid-Link Consulting Co.,Ltd |
P.O. BOX 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 09/28/2016 |
Decision Date | 02/09/2017 |
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
|
|
|