Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K213831 |
Device Name |
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle |
Applicant |
Gyrus ACMI, Inc. |
800 West Park Drive |
Westborough,
MA
01581
|
|
Applicant Contact |
Dolan Mills |
Correspondent |
Gyrus ACMI, Inc. |
800 West Park Drive |
Westborough,
MA
01581
|
|
Correspondent Contact |
Dolan Mills |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/08/2021 |
Decision Date | 01/04/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|