TruDi Shaver Blade

Ear, Nose, And Throat Stereotaxic Instrument

Acclarent, Inc.

The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Trudi Shaver Blade.

Pre-market Notification Details

Device IDK221037
510k NumberK221037
Device Name:TruDi Shaver Blade
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant Acclarent, Inc. 31 Technology Drive, Suite 200 Irvine,  CA  92618
ContactLeena Zalavadia
CorrespondentLeena Zalavadia
Acclarent, Inc. 31 Technology Drive, Suite 200 Irvine,  CA  92618
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-07
Decision Date2022-07-20

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