FDA.report

510(k) K243053

Device
Navient Image Guided Navigation System (ENT) (955-NC-NC)
Applicant
Claronav
510(k) number
K243053
Product code
PGW
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-20
Date received
2024-09-27
Regulation
882.4560
Classification name
Ear, Nose, And Throat Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Karen Wu
Address
1140 Sheppard Ave. W. Unit 10 Toronto CA M3K 2A2 M3K 2A2

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code PGW

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K223734ENT EMBrainlab AG2023-04-27
K221037TruDi Shaver BladeAcclarent, Inc.2022-07-20
K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker Corporation2022-07-12
K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH2021-07-19
K202609Instrument Clamps ElectromagneticStryker Corporation2020-10-09
K201174TruDi CuretteAcclarent, Inc.2020-08-12
K200723StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)Medtronic Navigation, Inc.2020-06-26
K193453TruDi ProbeAcclarent, Inc.2020-03-23
K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH2020-03-10
K193118TGS Guidewire and updated Scopis SoftwareStryker Ent2020-02-21
K193502TGS Universal Headrest with Mounting ArmStryker Ent2020-02-14
K192397TruDi Navigation SystemBiosense Webster2020-01-30
K190532TruDi NAV WireAcclarent, Inc.2019-05-03