FDA.report

510(k) K201174

Device
TruDi Curette
Applicant
Acclarent, Inc.
510(k) number
K201174
Product code
PGW  
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-12
Date received
2020-05-01
Regulation
882.4560
Classification name
Ear, Nose, And Throat Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Leena Sorathia
Address
31 Technology Dr. Irvine CA US 92618 92618

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
20705031465432TruDi CuretteACCLARENT, INC.2020-08-31
20705031465425TruDi CuretteACCLARENT, INC.2020-08-31

Legacy Summary

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FDA Review

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