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Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker

by Civco

510(k) K092619

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092619 Date13 Nov 2009ClearedStatusActive

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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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