Skip to content

Neolus Needle

by Terumo Europe N.V.

510(k) K001572

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK001572 Date14 Aug 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Neolus Needle is a hypodermic injection needle device. It is a single-use, stainless steel needle designed for parenteral drug delivery.

It is supplied ready-to-use in a soft blister pack and is available in a broad range of sizes for major applications. The device is manufactured by Terumo Europe N.V. and has received FDA 510(k) clearance under K001572 with product code FMI.

Other devices from Terumo Europe N.V.

See all devices from Terumo Europe N.V. →

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Neolus Needle used for?

    The Neolus Needle is designed for parenteral drug delivery, meaning it is used to administer medications or fluids beneath the skin, into muscle, or into a vein as a hypodermic injection needle.

  • Is the Neolus Needle reusable or single-use?

    The Neolus Needle is a single-use device, meaning it is intended for one procedure only and should be discarded after use to prevent cross-contamination and ensure patient safety.

  • How is the Neolus Needle supplied and packaged?

    The Neolus Needle is supplied ready-to-use in a soft blister pack, which maintains sterility and protects the needle until the point of clinical use.

  • What material is the Neolus Needle made from and what sizes are available?

    The Neolus Needle is made of stainless steel and is available in a broad range of sizes to support major clinical applications, though specific gauge and length dimensions are not detailed in the provided data.