PointerTube Straight and PointerTube Keat
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Fiagon GmbH
Identity
- Trade Name
- PointerTube Keat EUDAMEDFDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The device PointerTube Keat is a navigation probe with suction function for image guided surgery. The device is component to the Cube4D Navigation system. FDA UDI
- Model / Reference
- Cube 4D Navigation System EUDAMEDE 01 2107 EUDAMEDE012107 FDA UDI
- Description
- The device PointerTube Keat is a navigation probe with suction function for image guided surgery. The device is component to the Cube4D Navigation system. FDA UDI
Identifiers
- Catalog Number
- E012107 FDA UDI
- Primary DI / UDI-DI
- 04260759930348 EUDAMEDFDA UDI
- Basic UDI-DI
- 426075993E1006C EUDAMED
- Direct Marketing DI
- 04260759930348 EUDAMED
- 510(k) Number
- FDA Product Code
- PGW FDA 510(k)FDA UDI
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class IIa 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
The PointerTube Straight and PointerTube Keat are classified as Ear, Nose, and Throat Stereotaxic Instruments, designed to assist in the precise localization of anatomical structures during both open and percutaneous procedures. These devices provide navigational guidance, enhancing accuracy in surgical interventions within the neurology specialty.
The PointerTube Straight and PointerTube Keat are reusable instruments, intended for use with the Fiagon Navigation system in conjunction with electromagnetic tracking technology. They are regulated under FDA 510(k) clearance (K163416) and comply with MDR requirements, falling under device class II. No specific sterility or MRI safety information is provided in the data, though they are supplied as part of a navigational system for clinical use in neurosurgical settings.
Frequently asked questions
Are the PointerTube Straight and PointerTube Keat designed for single-use or can they be reused in multiple procedures?
The PointerTube Straight and PointerTube Keat are explicitly labeled as reusable instruments. They are intended to be used repeatedly within the Fiagon Navigation system, which relies on electromagnetic tracking technology for neurosurgical guidance. Reusability is a key feature to support cost-effective clinical workflows in sterile environments.
What neurosurgical procedures are these devices primarily intended to assist with, and how do they improve precision?
These devices—PointerTube Straight and PointerTube Keat—are Ear, Nose, and Throat Stereotaxic Instruments designed for neurosurgical procedures, particularly those requiring precise localization of anatomical structures. They assist in both open and percutaneous interventions by providing navigational guidance through electromagnetic tracking, which enhances accuracy during interventions like biopsies, lesion targeting, or electrode placements in the neurology specialty.
How are the PointerTube Straight and PointerTube Keat supplied, and what should clinicians consider regarding their handling?
The PointerTube Straight and PointerTube Keat are supplied as part of the Fiagon Navigation system, which integrates with electromagnetic tracking technology. Since they are reusable, clinicians must follow strict decontamination and sterilization protocols to ensure safe reuse across multiple procedures. While specific sterility instructions aren’t detailed in the data, adherence to standard medical device reprocessing guidelines is implied for clinical use in neurosurgery.
What regulatory pathways have these devices undergone, and how does that affect their clinical adoption?
The PointerTube Straight and PointerTube Keat have undergone FDA 510(k) clearance (K163416) and comply with MDR (Medical Device Regulation) requirements, classifying them as Class II devices. This regulatory route confirms their substantial equivalence to predicate devices and ensures they meet safety and performance standards for use in neurosurgical navigation. Clinicians can rely on this clearance for adoption in sterile, high-precision environments.
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: Fiagon Navigation - PointerTube Straight and PointerTube Keat, Fiagon Navigation PointerTube Straight and PointerTube Keat by FIAGON ..., ENT Series - Fiagon NA, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ...
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 | K163416 | Class II | Active |
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Manufacturer
- Manufacturer
- Fiagon GmbH
Sources (3)
- FDA 510(k) K163416 24 fields · synced Sep 18, 2026
- FDA UDI 81642c58-2cbb-4be0-ab93-06f6eb18ae92 36 fields · synced May 30, 2026
- EUDAMED f3fa5e68-f3a7-4031-ba36-bbc65ed75a16 61 fields · synced Jul 25, 2026