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Fiagon GMBH

Matched from indexed company URL: Fiagon GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103135883010313588Fiagon GMBH1N2026-01-01Neuendorfstr. 23b Hennigsdorf Brandenburg DE 16761

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04260759930003Integrated Headrest - The Integrated Headrest is mounted on the procedure chairs. It comprises a holder for a Navigation sensor, which creates an electromagnetic field above the cushion of the Integrated Headrest. The Integrated Headrest comes with the following adapters: 1) Chair Adapter 4020 2) Chair Adapter 2512.13364282241support@fiagon.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1713541702211551K230700RIWOtrack Navigation SystemOLO2023-11-20
1713541830886858K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation SystemPNZ2023-05-26
1713541524698845K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW2021-07-19
1713541707489955K201472VenSure Balloon Device, VenSure Nav Balloon DeviceLRC2020-08-26
1713541236421636K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UsePGW2020-03-10
1713541117062388K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatPGW2017-02-16
1713541595423212K163209Fiagon Navigation SystemHAW2017-09-14
1713542009641097K162176Fiagon Navigation SystemPGW2016-12-01
1713541249902926K161940Guidewire 0.6 Single UsePGW2016-09-18
1713541864809421K160479PointerShell Universal, PointerShell LSPGW2016-03-23
1713541862384421K160369GuideWirePGW2016-03-10
1713541813860999K151156Fiagon Navigation SystemHAW2016-04-01
1713541165589680K150473FlexPointer 1.5 mmPGW2015-04-16
1713541456250866K141456THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELLPGW2014-10-08
1713541767512797K133573FIAGON NAVIGATION SYSTEMPGW2014-04-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PGW102021-07-19
HAW22017-09-14
OLO12023-11-20
PNZ12023-05-26
LRC12020-08-26

PMN#

GUDID#

Fiagon Navigation Unit - The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomyThis also comprises of accessories 1) Extension cable instrument 2) Multi Instrument support3) FootSwitch 4) PC mouse 5) Service Keyboard 6)DVI monitor cable 7) VGA monitor cable 8) Monitor cable control 9) HDMI monitor cable 10) SDI video Cable 11) Power Cable (US)

Fiagon GmbH

2020-05-12

FlexPointer - The product FlexPointer are product variants of a navigated pointer probe forimage guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

Fiagon GmbH

2016-08-05

FlexPointer 1.5 - The product FlexPointer 1.5 are product variants of a navigatedpointer probe for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

Fiagon GmbH

2016-08-09

FlexTube 3mm - The products are variants of a navigated suction instrument for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

Fiagon GmbH

2016-08-08

FlexTube 4 mm - The products are variants of a navigated suction instrument for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate,and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT orMR based model of the anatomy.

Fiagon GmbH

2016-08-08

PointerTube Keat - The product is a variant of a navigated suction instrument for image guided surgical procedures .The instrument is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument is indicated for any medical condition in which the use ofstereotactic surgery may be appropriate and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.

Fiagon GmbH

2017-11-21

PointerTube Kennedy - The product is a variant of a navigated suction instrument for image guided surgical procedures .The instrument is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument is indicated for any medical condition in which the use ofstereotactic surgery may be appropriate and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.

Fiagon GmbH

2017-11-21

Navigation Headrest Universal - The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, whichcreates an electromagnetic field above the cushion of the Navigation headrest.The navigation headrest Universal comes with the following adapters:1) Adapters for siderails2)Adapters for Mizuho/Skytron Tables3)Adapters for Maquet Tables4)Adapters for Steris table5)Adapters for Eschmann Tables6)Flexarm adapters for for navigation sensor

Fiagon GmbH

2016-08-05

Guidewire 0.6 Single Use - The product GuideWire 0.6 Singel Use is a variant of a navigated probe for image guided surgical procedures with the XprESSLoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool.The instrument is an accessory to the Fiagon navigation system. It is designed to be used with the FiagonNavigation system and with XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool.The XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool are produced by EntellusMedical Inc./USA and are registered as 510K devices with the FDA. These are not subject of this instructions foruse.

Fiagon GmbH

2017-11-23

RegistrationPointer - The products RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guidedsurgical procedures. The instrument is part of the Fiagon Navigation – Extended instrument set ENT, which isdesigned to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigationsystem produced by Fiagon GmbH.The Fiagon Navigation - Extended Instrument Set ENT is intended as an aid for precisely locating anatomicalstructures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system usingelectromagnetic navigation.The Fiagon Navigation – Extended Instrument Set ENT is indicated for any medical condition in which the use ofstereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENTsurgery can be identified relative to a CT or MR based model of the anatomy.

Fiagon GmbH

2016-08-08

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