FDA.reportPublic FDA data

510(k) K223734

Device
ENT EM
Applicant
Brainlab AG
510(k) number
K223734
Product code
PGW
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-27
Date received
2022-12-13
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
No

Applicant Contact#

Contact
Esther Moreno Garcia
Address
Olof-Palme-Str 9 Munich DE 81829 81829

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PGW#

510(k), Device, Applicant table
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K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav2025-06-20
K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.2023-07-21
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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