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Abaris

by Traxtal Technologies, Inc.

510(k) K053610

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK053610 Date19 Apr 2006ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2769-2011 FDA Unclassified (pre-2012) initiated 1 Jun 2011

    PercuNav Tool Connection Unit may contain an electronic component that does not meet specification, which could cause registration difficulties and/or inaccurate instrument tracking.

    • Terminated Z-2219-2011 FDA Unclassified (pre-2012) initiated 1 Apr 2011

    The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.

    • Terminated Z-0617-2011 FDA Unclassified (pre-2012) initiated 10 Nov 2010

    The protective cover over the tip of the MP008R-B Button Probe may fall off, causing the probe tip to damage the packaging and compromise the sterility of the probe.

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  • Withdrawn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
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent