TruDi Curette

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 Curette.

Pre-market Notification Details

Device IDK201174
510k NumberK201174
Device Name:TruDi Curette
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant Acclarent, Inc. 31 Technology Drive Irvine,  CA  92618
ContactLeena Sorathia
CorrespondentLeena Sorathia
Acclarent, Inc. 31 Technology Drive Irvine,  CA  92618
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2020-08-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20705031465432 K201174 000
20705031465425 K201174 000

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