TruDi NAV Wire

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 Nav Wire.

Pre-market Notification Details

Device IDK190532
510k NumberK190532
Device Name:TruDi NAV Wire
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant Acclarent, Inc. 33 Technology Drive Irvine,  CA  92618
ContactLeena Sorathia
CorrespondentLeena Sorathia
Acclarent, Inc. 33 Technology Drive Irvine,  CA  92618
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-04
Decision Date2019-05-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20705031245911 K190532 000
20705031245904 K190532 000

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