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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 K201174
Device Name TruDi Curette
Applicant
Acclarent, Inc.
31 Technology Dr.
Irvine,  CA  92618
Applicant Contact Leena Sorathia
Correspondent
Acclarent, Inc.
31 Technology Dr.
Irvine,  CA  92618
Correspondent Contact Leena Sorathia
Regulation Number882.4560
Classification Product Code
PGW  
Date Received05/01/2020
Decision Date 08/12/2020
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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