The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Vente…
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Fiagon GmbH
Identity
- Trade Name
- RegistrationPointer EUDAMEDFDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The device RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The device is accessory to the Cube 4D Navigation system. FDA UDI
- Model / Reference
- Accessory to Cube4D Navigation System / Registration device tactile EUDAMEDE 01 2003 EUDAMEDE012003 FDA UDI
- Description
- The device RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The device is accessory to the Cube 4D Navigation system. FDA UDI
Identifiers
- Catalog Number
- E012003 FDA UDI
- Primary DI / UDI-DI
- 04260759930119 EUDAMEDFDA UDI
- Basic UDI-DI
- 426075993E0036D EUDAMED
- Direct Marketing DI
- 04260759930119 EUDAMED
- 510(k) Number
- FDA Product Code
- PGW FDA 510(k)FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
This device is an Ear, Nose, and Throat Stereotaxic Instrument, classified as a Class II medical device. It comprises reusable, electromagnetically navigated surgical instruments, including suction tubes, pointers, registration probes, and adapters, designed for use with the Fiagon Navigation system. The instruments feature integrated sensors at the tip, enabling precise tracking within a low-energy magnetic field generated by the navigation system.
The Fiagon Navigation Extended Instrument Set is intended for use in surgical procedures within the ENT specialty. It is supplied as a reusable set and has received FDA 510(k) clearance and MDR authorization. The Pointershell component allows for navigation compatibility with existing suction or shaver instruments via a clip-on design, ensuring quick calibration and immediate use. The set adheres to regulatory standards for electromagnetic compatibility and safety in surgical environments.
Frequently asked questions
What types of surgical procedures is this instrument set designed for within the ENT specialty?
The Fiagon Navigation Extended Instrument Set is designed for use in ENT (Ear, Nose, and Throat) surgical procedures, specifically where precise navigation is required. It integrates with the Fiagon Navigation system to enable real-time electromagnetic tracking of instruments like suction tubes, pointers, and registration probes, ensuring accurate placement during procedures such as sinus surgeries, cochlear implants, or other stereotaxic ENT interventions.
How is the Pointershell component useful in clinical practice, and what instruments can it adapt?
The Pointershell is a clip-on adapter that allows existing suction or shaver instruments to be quickly integrated with the Fiagon Navigation system. By attaching to these tools, the Pointershell enables electromagnetic tracking without requiring additional calibration, ensuring immediate compatibility and seamless navigation during surgery. This reduces setup time and enhances workflow efficiency.
Is this instrument set reusable, and if so, what maintenance or cleaning considerations should be noted?
Yes, the Fiagon Navigation Extended Instrument Set is reusable. Since it includes components like registration pointers, ventera pointers, and guidewires, proper cleaning and sterilization per manufacturer guidelines are essential to maintain electromagnetic sensor functionality and prevent cross-contamination. The reusable nature aligns with regulatory standards for electromagnetic compatibility and surgical safety.
What regulatory pathways has this device undergone, and how does that affect its use in clinical settings?
The device has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with U.S. and EU regulatory standards. This means it meets established safety and performance requirements for Class II medical devices, ensuring its suitability for clinical use in ENT navigation procedures while adhering to strict manufacturing and quality controls.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: The Fiagon Navigation - Extended Instrument Set Ent ..., The Fiagon Navigation - Extended Instrument Set Ent ..., ENT Series - Fiagon NA, The Fiagon Navigation - Extended Instrument Set Ent ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K141456 | Class II | Active |
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Manufacturer
- Manufacturer
- Fiagon GmbH
Sources (3)
- FDA 510(k) K141456 24 fields · synced Sep 18, 2026
- FDA UDI 65fc966a-8765-4a40-b2c0-2fc8fa6574aa 36 fields · synced May 27, 2026
- EUDAMED a8a46585-49bd-472b-bd5f-38567bc72c5b 61 fields · synced Jul 19, 2026