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Pidural Steroid System

by Professional Medical Device Consultants

510(k) K945484

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

31 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)SESK Substantially Equivalent — Kit · Traditional NumberK945484 Date2 Jun 1995ClearedStatusActive

Recalls

31 recalls · FDA

    • Terminated Z-0533-2014 FDA Class II initiated 28 Oct 2013

    Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.

    • Terminated Z-1943-2012 FDA Class III initiated 7 Jun 2012

    Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.

  • 29 recalls, same reason

    • Terminated Z-2099-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2079-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2105-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2082-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2087-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2104-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2083-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2101-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2097-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2089-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2103-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2095-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2107-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2096-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2098-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2106-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2081-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2100-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2092-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2102-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2108-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2086-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2093-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2090-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2094-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2080-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2085-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2088-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009
    • Terminated Z-2091-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009

    Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.

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
CAZ
Device Class
Class II
Regulation
21 CFR Part 868.5140
Advisory Committee
Anesthesiology
FDA Decision
SESK Substantially Equivalent — Kit