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9735894

by Medtronic Navigation Inc. 2 variants

Ref 9735894

9735894 is a multi-purpose stereotactic surgery system (EU MDR Class I; FDA Class II; FDA product code HAW, Neurological stereotaxic Instrument) made by Medtronic Navigation Inc., registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI 0763000B00003457K), cleared under FDA 510(k) K162309 on 31 Mar 2017 and listed in FDA GUDID since 18 Apr 2021 (UDI-DI 00763000423179), active as of 8 Nov 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162309

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00003457K Basic UDI-DI 00763000423179UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000423179 UDI-DI Date18 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK162309 Date31 Mar 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00003457K registered 14 Sep 2026 Active
  • FDA 510(k) K162309 decided 31 Mar 2017 Active
  • FDA GUDID UDI-DI 00763000423179 listed 18 Apr 2021 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1776-2024 FDA Class I initiated 26 Mar 2024

    Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

    • Terminated Z-1995-2020 FDA Class I initiated 9 Aug 2019

    Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).

Timeline

5 dated events

  1. Cleared FDA 510(k) K162309
  2. Recall initiated FDA recalls Z-1995-2020
  3. Listed FDA GUDID 00763000423179
  4. Recall initiated FDA recalls Z-1776-2024
  5. Registered EUDAMED 0763000B00003457K

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

Generic name
Multi-purpose stereotactic surgery system
Model / reference
9735894
Primary DI / UDI-DI
00763000423179
Basic UDI-DI
0763000B00003457K
510(k) Number
FDA product code
HAW
EMDN code
Z12011401 Surgical navigation system
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
Netherlands
GUDID distribution status
In Commercial Distribution

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.

Related devices

Category: Multi-purpose stereotactic surgery system

Cleared under the same submission (K162309)

and 8 more cleared under K162309

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION SYSTEM.

Other devices from Medtronic Navigation Inc.

See all devices from Medtronic Navigation Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)