FlexPointer 1.5 mm
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Fiagon GmbH
Identity
- Trade Name
- FlexPointer 1.5mm EUDAMEDFlexPointer 1.5 mm FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The device FlexPointer 1.5 mmis a navigation probe for image guided surgery. The device is component to the Cube4D Navigation system. FDA UDI
- Model / Reference
- Cube 4D Navigation System EUDAMEDE 01 2004 EUDAMEDE012004 FDA UDI
- Description
- The device FlexPointer 1.5 mmis a navigation probe for image guided surgery. The device is component to the Cube4D Navigation system. FDA UDI
Identifiers
- Catalog Number
- E012004 FDA UDI
- Primary DI / UDI-DI
- 04260759930317 EUDAMEDFDA UDI
- Basic UDI-DI
- 426075993E1006C EUDAMED
- Direct Marketing DI
- 04260759930317 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 FlexPointer 1.5 mm is an Ear, Nose, and Throat Stereotaxic Instrument, designed for precise procedural guidance in neurological applications. Its flexible design enables targeted access and manipulation within confined anatomical spaces, supporting minimally invasive techniques in otolaryngology and related specialties.
Supplied as a single-use device, the FlexPointer 1.5 mm is intended for sterile use in clinical settings. It adheres to FDA 510(k) and MDR regulatory standards, with a clearance type designated as Special under the Neurology advisory committee. The device is classified as Class II under the FDA’s medical device regulations, ensuring compliance with stringent manufacturing and performance requirements.
Frequently asked questions
What is the primary purpose of the FlexPointer 1.5 mm in clinical settings?
The FlexPointer 1.5 mm is designed for precise procedural guidance in neurological applications within the ear, nose, and throat (ENT) specialty. Its flexible design allows targeted access and manipulation in confined anatomical spaces, making it ideal for minimally invasive techniques in otolaryngology and related neurological procedures.
Is the FlexPointer 1.5 mm intended for single-use or reusable applications?
The FlexPointer 1.5 mm is explicitly supplied as a single-use device, ensuring sterility for clinical use. This design choice aligns with best practices for reducing infection risks and maintaining hygiene in medical procedures.
How is the regulatory status of the FlexPointer 1.5 mm defined, and what does this mean for its use?
The FlexPointer 1.5 mm is cleared under the FDA’s 510(k) pathway with a classification as Class II, indicating it meets stringent manufacturing and performance standards. It was also authorized under the Medical Device Regulation (MDR) in the EU. The device’s clearance type is designated as Special under the Neurology advisory committee, reflecting its specialized use in neurological procedures.
What storage or handling considerations should be taken for the FlexPointer 1.5 mm?
Since the FlexPointer 1.5 mm is a single-use, sterile device, it should be stored in its original packaging until use to preserve sterility. The packaging must remain unopened and protected from contamination until the device is ready for immediate clinical application.
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.
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 | K150473 | Class II | Active |
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Manufacturer
- Manufacturer
- Fiagon GmbH
Sources (3)
- FDA 510(k) K150473 24 fields · synced Sep 18, 2026
- FDA UDI 0c07d7d4-6d21-4853-9550-6401a484aec8 36 fields · synced May 30, 2026
- EUDAMED 197d1cf5-ec28-4f78-9e25-4c7353d3d0dd 61 fields · synced Jul 30, 2026