Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010313588

FEI Number

3010313588

Entity Name

Fiagon GMBH

City/State/Country

Hennigsdorf Brandenburg, DE

Establishment Address

Neuendorfstr. 23b, Hennigsdorf Brandenburg 16761, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fiagon GmbH (Owner Number: 10046786)

Owner / Operator Contact Address

Neuendorfstr. 23b, Hennigsdorf, DE-BB 16761, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230700

PMA Number

N/A

All Registered Proprietary Names

FlexTube 4 mm PointerShell 4 mm PointerShell 3 mm PointerShell 5 mm RegistrationPointer FlexTube 3 mm FlexTube 3 Single Use FlexPointer 1.5 Single Use FlexPointer 1.5 GuideWire 0.6 Single Use VirtuEye Navigation Sensor NanoRest Cube Navigation System Navigation Unit Cube 4D VenSure 4D Balloon Dilation System VenSure Nav Balloon Dilation System VenSure Balloon Dilation System VenSure Light Balloon Dilation System VenSure ET Balloon Dilation System FlexPointer Fiagon Navigation System FinePointer Localizer Adhesive pad C-Type RIWOtrack Flexsensor Localizer K-Wire MapperBridge Adapter for Clipsensor Navigation Sensor Flexarm MultiPad RIWOtrack Cube4D RIWOtrack Clipsensor Adapter for Flexsensor RIWOtrack Navigation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2014-12-03
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-03-27
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-12-11
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-02-22
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-07-28
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2023-07-06
PNZ	Eustachian Tube Balloon Dilation Device	Ear, Nose, Throat	Class 2	874.4180	2023-07-06
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2014-05-13
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

Matthew Jones Business: Fiagon NA Email: mjones@h-f.us Phone: (512) 3838580

Related Public Records

Same Entity

Fiagon GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K200041	Fiagon GmbH	FlexPointer 1.5 Single Use, FlexTube 3 Single Use	2020-03-10
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K171761	Acclarent, Inc.	ACCLARENT AERA Eustachian Tube Balloon Dilation System	2018-01-16
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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3005172759	ACCLARENT, INC.	Irvine, CA, US
3003418325	Integra LifeSciences Corporation	Princeton, NJ, US
3010273872	Synergy Health AST, SRL	Alajuela, CR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010313588. Last updated year: 2026. Please use registration number 3010313588 when referencing this establishment in official correspondence.