# FlexPointer 1.5 mm

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/flexpointer-1-5-mm-pgw>
- Manufacturer: [Fiagon GmbH](https://devicerts.com/manufacturers/fiagon-gmbh) (Germany)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: PGW
- EMDN: Z12011401 SURGICAL NAVIGATION SYSTEM
- GMDN: Multi-purpose stereotactic surgery system (45199)

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 04260759930317 · listed 2025-01-16 · status: Listed (GUDID: in commercial distribution)
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 426075993E1006C · UDI-DI 04260759930317 · registered 2024-07-10 · status: Active
- **510(k)** · FDA 510(k) · United States · K150473 · decision 2015-04-16 · decision SESE · status: Active

## Recalls

No recall on record.

## Identity

- Trade name: FlexPointer 1.5mm [EUDAMED]; FlexPointer 1.5 mm [FDA GUDID (AccessGUDID)]
- Generic name: Multi-purpose stereotactic surgery system [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: Cube 4D Navigation System [EUDAMED]; E 01 2004 [EUDAMED]; E012004 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 04260759930317 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 426075993E1006C [EUDAMED]
- Direct marketing DI: 04260759930317 [EUDAMED]
- 510(k) Number: K150473 [FDA 510(k), FDA GUDID (AccessGUDID)]
- FDA product code: PGW [FDA 510(k), FDA GUDID (AccessGUDID)]
- EMDN code: Z12011401 [EUDAMED]
- GMDN term: Multi-purpose stereotactic surgery system (45199) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA 510(k), FDA GUDID (AccessGUDID)]
- Regulation: 21 CFR Part 882.4560 [FDA 510(k), FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- Advisory committee: Neurology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Moist Heat or Steam Sterilization [FDA GUDID (AccessGUDID)]
- MRI safety: MR Unsafe [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: FlexPointer 1.5 mm, Fiagon GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/flexpointer-1-5-mm-pgw (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-06
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/flexpointer-1-5-mm-pgw.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/flexpointer-1-5-mm-pgw
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.