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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 K252043
Device Name Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
Applicant
Olympus Winter & Ibe GmbH
Kuehnstrasse 61
Hamburg,  DE 22045
Applicant Contact Michaela Soukopova
Correspondent
Olympus Surgical Technologies America
Gyrus Acmi, Inc.
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Teffany Hutto
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/30/2025
Decision Date 09/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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