FlexPointer 1.5 Single Use, FlexTube 3 Single Use
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Fiagon GmbH
Identifiers
- 510(k) Number
- K200041 FDA 510(k)
- FDA Product Code
- PGW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FlexPointer 1.5 Single Use and FlexTube 3 Single Use are classified as Ear, Nose, and Throat Stereotaxic Instruments. These devices are designed to assist in the precise localization of anatomical structures during open or percutaneous procedures, enhancing navigational accuracy in surgical settings.
The devices are intended for use with the Fiagon Navigation system, which employs electromagnetic navigation for guidance. Supplied as single-use items, they are regulated under FDA 510(k) clearance (K200041) and the MDR, with a product code of PGW. They fall under Class II with Special Controls and are intended for use in neurology procedures.
Frequently asked questions
Are the FlexPointer 1.5 and FlexTube 3 designed for reuse or single-use, and how does this affect their clinical workflow?
The FlexPointer 1.5 and FlexTube 3 are explicitly labeled as single-use devices. This design ensures sterility and reduces the risk of cross-contamination between patients, simplifying workflow by eliminating the need for reprocessing or sterilization between cases. Clinicians can open a new device directly before use, improving efficiency and compliance with infection control protocols.
What surgical specialties or procedures are these devices primarily intended to support, and how do they enhance precision?
These devices are classified under Ear, Nose, and Throat (ENT) Stereotaxic Instruments and are specifically designed for neurology procedures. They assist in precise localization of anatomical structures during open or percutaneous surgeries by integrating with the Fiagon Navigation system, which uses electromagnetic navigation for real-time guidance. This reduces reliance on manual palpation and improves accuracy in delicate procedures like deep brain stimulation or tumor resection.
How are the FlexPointer 1.5 and FlexTube 3 regulated, and what does the product code PGW indicate about their classification?
Both devices are regulated under FDA 510(k) clearance (K200041) and the EU Medical Device Regulation (MDR). The product code PGW categorizes them as Class II devices with Special Controls, indicating they require additional scrutiny due to their role in neurological navigation. This classification reflects their use in critical procedures where precision and safety are paramount, aligning with the advisory committee designation for neurology procedures.
What storage or handling considerations should clinicians keep in mind for these single-use devices?
As single-use items, the FlexPointer 1.5 and FlexTube 3 should be stored in their original, sealed packaging to maintain sterility until use. The packaging is likely designed to protect against contamination and physical damage. Clinicians should avoid exposing the devices to extreme temperatures, moisture, or direct sunlight, as these factors could compromise their integrity before use. Always check the packaging for expiration dates or damage before opening.
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: FlexPointer 1.5 Single Use, FlexTube 3 Single Use by Fiagon GmbH | FDA ..., K200041 FDA 510(k) - FlexPointer 1.5 Single Use | Fiagon GmbH, FlexPointer 1.5 Single Use, FlexTube 3 Single Use… - FDA.report
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 | K200041 | Class II | Active |
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Manufacturer
- Manufacturer
- Fiagon GmbH
Sources (2)
- FDA 510(k) K200041 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026