Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K231777 |
Device Name |
Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) |
Applicant |
Olympus Winter & Ibe GmbH |
Kuehnstrasse 61 |
Hamburg,
DE
22045
|
|
Applicant Contact |
Ian Pericevic |
Correspondent |
Olympus Surgical Tech. America; Gyrus ACMI, Inc. |
800 West Park Drive |
Westborough,
MA
01581
|
|
Correspondent Contact |
Dolan Mills |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/16/2023 |
Decision Date | 08/18/2023 |
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
|