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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

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#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH2026-06-02
K253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.2026-03-16
K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.2023-07-21
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