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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ear, Nose, And Throat Stereotaxic Instrument
510(k) Number K221037
Device Name TruDi Shaver Blade
Applicant
Acclarent, Inc.
31 Technology Dr., Suite 200
Irvine,  CA  92618
Applicant Contact Leena Zalavadia
Correspondent
Acclarent, Inc.
31 Technology Dr., Suite 200
Irvine,  CA  92618
Correspondent Contact Leena Zalavadia
Regulation Number882.4560
Classification Product Code
PGW  
Subsequent Product Code
ERL  
Date Received04/07/2022
Decision Date 07/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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