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Stealth Autoguide™ System 28340

by Medtronic Navigation Inc.

Ref 28340

Stealth Autoguide™ System 28340 is a device classified as Class I in the EU and Class II in the US made by Medtronic Navigation Inc., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 0763000B00010567G), cleared under FDA 510(k) K191597 on 1 Nov 2019 and listed in FDA GUDID since 5 Aug 2022 (UDI-DI 00763000536411), active as of 8 Nov 2026. One FDA recall is 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) K191597

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 Number0763000B00010567G Basic UDI-DI 00763000536411UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000536411 UDI-DI Date5 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191597 Date1 Nov 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00010567G registered 25 Sep 2026 Active
  • FDA 510(k) K191597 decided 1 Nov 2019 Active
  • FDA GUDID UDI-DI 00763000536411 listed 5 Aug 2022 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0417-2022 FDA Class II initiated 9 Nov 2021

    A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury. Per 11/24/21 firm email: The Bundle Autoguide Reg Kit does not have a model number. The Bundle Autoguide Reg Kit is internal terminology and not visible to the customer and are used as sales and shipping configuration only. When this sales bundle is chosen by an internal Medtronic Sales Representative the devices included in the bundle are individually packaged and labeled and sent to the customer in a single shipment. The devices included in the bundle are ordered, packed, and shipped as individual medical devices with unique model numbers, which is the reason that the Autoguide Tracker (28248) and the Stealth Autoguide Basic Instrument Kit (9736188) are the only part numbers subject to this FCA.

Timeline

4 dated events

  1. Cleared FDA 510(k) K191597
  2. Recall initiated FDA recalls Z-0417-2022
  3. Listed FDA GUDID 00763000536411
  4. Registered EUDAMED 0763000B00010567G

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
Stealth Autoguide™ System
Generic name
Surgical drill guide obturator
Device name
Autoguide Obturators
Model / reference
28340
Primary DI / UDI-DI
00763000536411
Basic UDI-DI
0763000B00010567G
510(k) Number
FDA product code
HAW
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Surgical drill guide obturator
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
Sterilisation method
Moist Heat or Steam Sterilization

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: Surgical drill guide obturator

Cleared under the same submission (K191597)

and 8 more cleared under K191597

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Medtronic Navigation Inc.

See all devices from Medtronic Navigation Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)