FlexPointer 1.5 mm Stereotaxic Instrument

Regulatory status

as of registry sync 6 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number04260759930317 UDI-DI	Date16 Jan 2025Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDR EUDAMED	Number426075993E1006C Basic UDI-DI 04260759930317UDI-DI	Date10 Jul 2024Registered	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Special	NumberK150473	Date16 Apr 2015Cleared	StatusActive

Official records

EUDAMED public site Basic UDI-DI 426075993E1006C — open Devices and search for it
AccessGUDID record UDI-DI 04260759930317
FDA 510(k) database 510(k) number K150473

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 426075993E1006C registered 10 Jul 2024 Active
FDA 510(k) K150473 decided 16 Apr 2015 Active
FDA GUDID UDI-DI 04260759930317 listed 16 Jan 2025 Listed

Timeline

3 dated events

16 Apr 2015 Cleared FDA 510(k) K150473
10 Jul 2024 Registered EUDAMED 426075993E1006C
16 Jan 2025 Listed FDA GUDID 04260759930317

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

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

Primary DI / UDI-DI: 04260759930317
Basic UDI-DI: 426075993E1006C
Direct marketing DI: 04260759930317
510(k) Number: K150473
FDA product code: PGW
EMDN code: Z12011401 Surgical navigation system
GMDN term: Multi-purpose stereotactic surgery system

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

Sterilisation method: Moist Heat or Steam Sterilization
MRI safety: MR Unsafe

Truth per registry

3 sources · 2 fields differ

Field	EUDAMED	510(k)	GUDID
Model / reference	EUDAMED Cube 4D Navigation System E 01 2004	510(k) —	GUDID E012004
Device class	EUDAMED Class IIa	510(k) Class II	GUDID Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

TruDi Probe K193453 23 Mar 2020 FDA record · FDA summary
FlexPointer 1.5 Single Use, FlexTube 3 Single Use K200041 10 Mar 2020 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under K150473

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K150473
		UDI-DI	Size and differences
FlexPointer 1.5 Fiagon GmbH	1	EFIAE0120041	—	No longer on the market
FlexPointer 1.5 mm E012004 Fiagon GmbH	E012004 / E012004	04260759930317	—	On the market

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION SYSTEM.

Other devices from Fiagon GmbH

Adhesive Pad

Class I
Localizer Adhesive Pad - Single use

Class I
Cube 4D Navigation System, VirtuEye Pro

Class II
Flexarm Universal

Class I

See all devices from Fiagon GmbH →

Properties

Sterilise before use
Prescription use
Serial number
Manufacturing date

Other properties (21, all answered No)