Skip to content

General Purpose Sensor 10441627

by Civco Medical Instruments Co., Inc.

Ref 10441627

General Purpose Sensor 10441627 is a device classified as Class I in the EU and Class II in the US made by Civco Medical Instruments Co., Inc., registered in EUDAMED on 16 May 2026 (Basic UDI-DI 0841436101TD103A1NH), cleared under FDA 510(k) K092619 on 13 Nov 2009 and listed in FDA GUDID since 22 Aug 2017 (UDI-DI 00841436100335), active as of 23 Oct 2026. 17 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

8 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K092619

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841436101TD103A1NH Basic UDI-DI 00841436100335UDI-DIDate16 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841436100335 UDI-DI Date22 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK092619 Date13 Nov 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0841436101TD103A1NH registered 16 May 2026 Active
  • FDA 510(k) K092619 decided 13 Nov 2009 Active
  • FDA GUDID UDI-DI 00841436100335 listed 22 Aug 2017 Listed

Recalls

17 recalls · 8 ongoing · FDA

  • 8 recalls, same reason

    • Ongoing Z-1738-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1736-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1735-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1737-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1732-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1731-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1734-2026 FDA Class II initiated 2 Mar 2026
    • Ongoing Z-1733-2026 FDA Class II initiated 2 Mar 2026

    There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

  • 4 recalls, same reason

    • Terminated Z-0396-2022 FDA Class II initiated 8 Oct 2021
    • Terminated Z-0397-2022 FDA Class II initiated 8 Oct 2021
    • Terminated Z-0398-2022 FDA Class II initiated 8 Oct 2021
    • Terminated Z-0395-2022 FDA Class II initiated 8 Oct 2021

    There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

  • 5 recalls, same reason

    • Terminated Z-1955-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1952-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1953-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1954-2012 FDA Class II initiated 7 May 2012
    • Terminated Z-1956-2012 FDA Class II initiated 7 May 2012

    The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.

Timeline

20 dated events

  1. Recall initiated FDA recalls Z-0395-2022
  2. Recall initiated FDA recalls Z-1738-2026
  3. Recall initiated FDA recalls Z-1736-2026
  4. Recall initiated FDA recalls Z-1735-2026
  5. Recall initiated FDA recalls Z-1737-2026
  6. Recall initiated FDA recalls Z-1732-2026
  7. Recall initiated FDA recalls Z-1731-2026
  8. Recall initiated FDA recalls Z-1734-2026
  9. Recall initiated FDA recalls Z-1733-2026
  10. Registered EUDAMED 0841436101TD103A1NH

10 earlier events are in the sections above.

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
General Purpose Sensor
Generic name
Patient positioning sensor
Device name
Electromagnetic Tracking – Tracking Tools (General Purpose Sensor)
Model / Ref / Catalog
10441627
Description
Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY™ , driveBAY™ 2, trakSTAR™ , or trakSTAR™ 2 trackers
Primary DI / UDI-DI
00841436100335
Basic UDI-DI
0841436101TD103A1NH
Direct marketing DI
20841436118174
510(k) Number
FDA product code
IYO
EMDN code
A018099 Needles - other accessories
GMDN term
Patient positioning sensor
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Width — 7 Inch
Length — 1.95 Inch

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: Patient positioning sensor

Cleared under the same submission (K092619)

and 8 more cleared under K092619

Similar devices in this category

Other devices filed under NEEDLES - OTHER ACCESSORIES.

Other devices from Civco Medical Instruments Co., Inc.

See all devices from Civco Medical Instruments Co., Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)