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Biopsy Starter Kit H4908ND

by Civco Medical Instruments Co., Inc.

Part of a family of 11 devices: see the family page

Ref H4908ND

Biopsy Starter Kit H4908ND is a device classified as Class IIa in the EU and Class II in the US made by Civco Medical Instruments Co., Inc., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 0841436101TD103A2aUB), cleared under FDA 510(k) K092619 on 13 Nov 2009 and listed in FDA GUDID since 22 Aug 2017 (UDI-DI 00841436109321), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841436101TD103A2aUB Basic UDI-DI 00841436109321UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841436109321 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 0841436101TD103A2aUB registered 27 May 2026 Active
  • FDA 510(k) K092619 decided 13 Nov 2009 Active
  • FDA GUDID UDI-DI 00841436109321 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 0841436101TD103A2aUB

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
Biopsy Starter Kit
Generic name
Electromagnetic surgical navigation/tracking system
Device name
Electromagnetic Tracking – Tracking Tools (UltraPro II Tracking Brackets)
Model / Ref / Catalog
H4908ND
Primary DI / UDI-DI
00841436109321
Basic UDI-DI
0841436101TD103A2aUB
Direct marketing DI
20841436117153
510(k) Number
FDA product code
IYO
EMDN code
A018002 Needle guides
GMDN term
Electromagnetic surgical navigation/tracking system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 2.4 Inch
Width — 2.4 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Electromagnetic surgical navigation device tracking system

Cleared under the same submission (K092619)

and 8 more cleared under K092619

Similar devices in this category

Other devices filed under NEEDLE GUIDES.

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
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)