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AVID TruCustom RM1705A_0004

by Avid Medical, Inc.

AVID TruCustom RM1705A_0004 is a Class II device made by Avid Medical, Inc., cleared under FDA 510(k) K854816 on 19 Dec 1985 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 10809160002131), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K854816

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10809160002131 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK854816 Date19 Dec 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K854816 decided 19 Dec 1985 Active
  • FDA GUDID UDI-DI 10809160002131 listed 15 Sep 2016 Listed

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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K854816
  2. Recall initiated FDA recalls Z-1544-2015
  3. Recall initiated FDA recalls Z-2056-2015
  4. Listed FDA GUDID 10809160002131

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AVID TruCustom
Generic name
Epidural needle, non-threaded
Model / reference
RM1705A_0004
Primary DI / UDI-DI
10809160002131
510(k) Number
FDA product code
BSP
GMDN term
Epidural needle, non-threaded
Device class
Class II
Regulation number
868.5150
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Epidural needle, non-threaded

Cleared under the same submission (K854816)

and 8 more cleared under K854816

Similar devices

Other devices filed under FDA product code BSP (NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)).

Other devices from Avid Medical, Inc.

See all devices from Avid Medical, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)