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PointerShell Universal E012904

by Fiagon GmbH

Ref E 01 2904Model Accessory to Cube4D Navigation System / Instrument tracker

PointerShell Universal E012904 is a multi-purpose stereotactic surgery system (EU MDR Class I; FDA Class II; FDA product code PGW, Ear, Nose, And Throat Stereotaxic Instrument) made by Fiagon GmbH, registered in EUDAMED on 10 Jul 2024 (Basic UDI-DI 426075993E0056H), cleared under FDA 510(k) K160479 on 23 Mar 2016 and listed in FDA GUDID since 2 Sep 2024 (UDI-DI 04260759930393), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160479

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260759930393 UDI-DI Date2 Sep 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number426075993E0056H Basic UDI-DI 04260759930393UDI-DIDate10 Jul 2024RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK160479 Date23 Mar 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 426075993E0056H registered 10 Jul 2024 Active
  • FDA 510(k) K160479 decided 23 Mar 2016 Active
  • FDA GUDID UDI-DI 04260759930393 listed 2 Sep 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160479
  2. Registered EUDAMED 426075993E0056H
  3. Listed FDA GUDID 04260759930393

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
PointerShell Universal
Generic name
Multi-purpose stereotactic surgery system
Model / Ref / Catalog
Accessory to Cube4D Navigation System / Instrument tracker EUDAMED
E 01 2904 EUDAMED
E012904 GUDID
Primary DI / UDI-DI
04260759930393
Basic UDI-DI
426075993E0056H
Direct marketing DI
04260759930393
510(k) Number
FDA product code
PGW
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Multi-purpose stereotactic surgery system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Accessory to Cube4D Navigation System / Instrument tracker
E 01 2904
GUDID
E012904
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Multi-purpose stereotactic surgery system

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Fiagon GmbH

See all devices from Fiagon GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)