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Radiolucent Drapelink Patient Reference Array

by Brainlab SE

Ref 19152-02

Radiolucent Drapelink Patient Reference Array (19152-02) is a device classified as Class I in the EU and Class II in the US made by Brainlab SE, cleared under FDA 510(k) K262257 on 30 Sep 2026 (3 earlier submissions), registered in EUDAMED on 17 May 2024 (Basic UDI-DI 4056481DrapeLinkArrayWK) and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 04056481004545), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

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 ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K262257

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK262257 Date30 Sep 2026DecidedStatusActive
European UnionCE/MDR EUDAMED Number4056481DrapeLinkArrayWK Basic UDI-DI 04056481004545UDI-DIDate17 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04056481004545 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • FDA 510(k) K262257 decided 30 Sep 2026 Active· +3 more in the status table
  • EUDAMED Basic UDI-DI 4056481DrapeLinkArrayWK registered 17 May 2024 Active
  • FDA GUDID UDI-DI 04056481004545 listed 15 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0056-2021 FDA Class II initiated 31 Aug 2020

    Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.

    • Terminated Z-0598-2016 FDA Class I initiated 22 Apr 2013

    Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.

Timeline

8 dated events

  1. Cleared FDA 510(k) K092467
  2. Recall initiated FDA recalls Z-0598-2016
  3. Listed FDA GUDID 04056481004545
  4. Recall initiated FDA recalls Z-0056-2021
  5. Cleared FDA 510(k) K192703
  6. Registered EUDAMED 4056481DrapeLinkArrayWK
  7. Cleared FDA 510(k) K252562
  8. Cleared FDA 510(k) K262257

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
Radiolucent Drapelink Patient Reference Array EUDAMED
Cranial Reference Array Drapelink GUDID
Generic name
Robotic surgical navigation system
Device name
Radiolucent DrapeLink Array
Model / Ref / Catalog
19152-02
Primary DI / UDI-DI
04056481004545
Basic UDI-DI
4056481DrapeLinkArrayWK
Direct marketing DI
04056481004545
510(k) Number
FDA product code
HAW, OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Robotic surgical navigation 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 Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
DE-MF-000006183

Related devices

Category: Neurological stereotactic surgery system

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Brainlab SE

See all devices from Brainlab SE →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)