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Coaxial Biopsy Needle

by Bard Gynecology and Radiology

510(k) K936194

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 NumberK936194 Date22 Mar 1994ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2547-2016 FDA Class II initiated 6 Jul 2016

    May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.

    • Terminated Z-1396-2016 FDA Class II initiated 4 Feb 2016

    Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial.

    • Terminated Z-0913-06 FDA Unclassified (pre-2012) initiated 1 May 2006

    Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected.

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  • Withdrawn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
FCG
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent