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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 K213831
Device Name Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
Applicant
Gyrus Acmi, Inc.
800 W. Park Dr.
Westborough,  MA  01581
Applicant Contact Dolan Mills
Correspondent
Gyrus Acmi, Inc.
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Dolan Mills
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/08/2021
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
Predetermined Change
Control Plan Authorized		 No
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