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Epidural Anesthesia Needles

by Reganes, Inc.

510(k) K854816

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK854816 Date19 Dec 1985ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2056-2015 FDA Class II initiated 1 May 2015

    Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch).

    • Terminated Z-1544-2015 FDA Class II initiated 30 Mar 2015

    A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.

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  • Withdrawn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
BSP
Device Class
Class II
Regulation
21 CFR Part 868.5150
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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