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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 W Park Dr.
Westborough,  MA  01581
Correspondent Contact Dolan Mills
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/16/2023
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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