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Acu-Needle 0NP2015

by Acuderm, Inc.

Acu-Needle 0NP2015 is a Class II device made by Acuderm, Inc., cleared under FDA 510(k) K874024 on 23 Nov 1987 and listed in FDA GUDID since 3 Jan 2020 (UDI-DI 00814105020357), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K874024

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814105020357 UDI-DI Date3 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK874024 Date23 Nov 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K874024 decided 23 Nov 1987 Active
  • FDA GUDID UDI-DI 00814105020357 listed 3 Jan 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K874024
  2. Listed FDA GUDID 00814105020357

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Acu-Needle
Generic name
Hypodermic needle, single-use
Model / reference
0NP2015
Description
20 standard gauge 1 1/2" needle, high quality economical plastic hub hypodermic needles. Fits both luer slip and luer lock syringes, tri-beveled tip. Sterile
Primary DI / UDI-DI
00814105020357
510(k) Number
FDA product code
FMI
GMDN term
Hypodermic needle, single-use
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hypodermic needle, single-use

Cleared under the same submission (K874024)

and 8 more cleared under K874024

Similar devices in this category

Other devices filed under Hypodermic needle, single-use.

Other devices from Acuderm, Inc.

  • Acu-Evac Adpack

    Class II

  • Acu-Evac ARMC1

    Class II

  • Acu-Evac Adlpack

    Class II

  • Acu-Punch

    Class IIa

See all devices from Acuderm, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)