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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K212650
Device Name Celeris, Disposable Sinus Debrider
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 Number874.4250
Classification Product Code
ERL  
Date Received08/23/2021
Decision Date 01/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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