Buzz Navigation (Ceiling-Mounted)

Ref 15706

Buzz Navigation (Ceiling-Mounted) (15706) is a device classified as Class IIb in the EU and Class II in the US made by Brainlab SE, cleared under FDA 510(k) K262257 on 30 Sep 2026 (6 earlier submissions), registered in EUDAMED on 16 Jul 2025 (Basic UDI-DI 4056481BuzzNavigationE3) and listed in FDA GUDID since 31 Oct 2018 (UDI-DI 04056481140847), active as of 22 Oct 2026. 5 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

5 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K262257

+6 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK262257	Date30 Sep 2026Decided	StatusActive
European Union	CE/MDR EUDAMED	Number4056481BuzzNavigationE3 Basic UDI-DI 04056481140847UDI-DI	Date16 Jul 2025Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK243698	Date28 Jan 2025Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK223864	Date9 Sep 2023Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK223288	Date21 Jul 2023Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK221618	Date30 Aug 2022Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK183605	Date29 Aug 2019Decided	StatusActive
United States	GUDID listing GUDID	Number04056481140847 UDI-DI	Date31 Oct 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK092467	Date6 May 2010Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 4056481BuzzNavigationE3 — open Devices and search for it
AccessGUDID record UDI-DI 04056481140847
FDA 510(k) database 510(k) number K262257
FDA 510(k) database 510(k) number K243698
FDA 510(k) database 510(k) number K223864
FDA 510(k) database 510(k) number K223288
FDA 510(k) database 510(k) number K221618
FDA 510(k) database 510(k) number K183605
FDA 510(k) database 510(k) number K092467

Across registries

3 registries list this device

FDA 510(k) K262257 decided 30 Sep 2026 Active· +6 more in the status table
EUDAMED Basic UDI-DI 4056481BuzzNavigationE3 registered 16 Jul 2025 Active
FDA GUDID UDI-DI 04056481140847 listed 31 Oct 2018 Listed

Recalls

5 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-2925-2020 FDA Class II initiated 20 Aug 2020
Holding force of the Positioning Arm can be reduced by prolonged non-use.
2 recalls, same reason
- Terminated Z-2793-2020 FDA Class II initiated 16 Jul 2020
- Terminated Z-2792-2020 FDA Class II initiated 16 Jul 2020
Incorrect manufacturer calibration
- 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

14 dated events

16 Jul 2020 Recall initiated FDA recalls Z-2793-2020
16 Jul 2020 Recall initiated FDA recalls Z-2792-2020
20 Aug 2020 Recall initiated FDA recalls Z-2925-2020
31 Aug 2020 Recall initiated FDA recalls Z-0056-2021
30 Aug 2022 Cleared FDA 510(k) K221618
21 Jul 2023 Cleared FDA 510(k) K223288
9 Sep 2023 Cleared FDA 510(k) K223864
28 Jan 2025 Cleared FDA 510(k) K243698
16 Jul 2025 Registered EUDAMED 4056481BuzzNavigationE3
30 Sep 2026 Cleared FDA 510(k) K262257

4 earlier events are in the sections above.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

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

Specification

EUDAMED · GUDID

Generic name: Electromagnetic/optical surgical navigation/tracking system
Model / Ref / Catalog: 15706

Primary DI / UDI-DI: 04056481140847
Basic UDI-DI: 4056481BuzzNavigationE3
510(k) Number: K092467
K183605
K221618
K223288
K223864
K243698
K262257
FDA product code: HAW, OLO
EMDN code: Z12011480 Surgical navigation instruments - hardware accessories
GMDN term: Electromagnetic/optical surgical navigation/tracking system

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 882.4560
System or procedure pack: System which is a device in itself
EU registration type: Standard device
EU market of registration: Germany
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED Class IIb	GUDID Class II

Device class is stated on each registry's own scale: Class IIb 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

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (22, all answered No)