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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 K212643
Device Name POWERSEAL Curved Jaw Sealer and Divider, Double Action
Applicant
Olympus Surgical Technologies America
9600 Louisiana Blvd. N.
Brooklyn Park,  MN  55455
Applicant Contact Christina Flores
Correspondent
Olympus Surgical Technologies America
9600 Louisiana Blvd. N.
Brooklyn Park,  MN  55455
Correspondent Contact Christina Flores
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/20/2021
Decision Date 09/27/2021
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
Recalls CDRH Recalls
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