Device Classification Name |
stapler, surgical
|
510(k) Number |
K221629 |
Device Name |
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) |
Applicant |
Covidien |
60 Middletown Avenue |
North Haven,
CT
06473
|
|
Applicant Contact |
Katherine Y. Choi |
Correspondent |
Covidien |
60 Middletown Avenue |
North Haven,
CT
06473
|
|
Correspondent Contact |
Katherine Y. Choi |
Regulation Number | 878.4740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/06/2022 |
Decision Date | 02/22/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|