Device Classification Name |
Stapler, Surgical
|
510(k) Number |
K234039 |
Device Name |
AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) |
Applicant |
Lexington Medical, Inc. |
23 Crosby Drive |
Bedford,
MA
01730
|
|
Applicant Contact |
Sali Gully |
Correspondent |
Lexington Medical, Inc. |
23 Crosby Drive |
Bedford,
MA
01730
|
|
Correspondent Contact |
Sali Gully |
Regulation Number | 878.4740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/21/2023 |
Decision Date | 05/07/2024 |
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
|
|
|