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Safety Hypodermic Needles With/Without Syringe

by Wuxi Yushou Medical Applicances Co., Ltd.

510(k) K130212

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130212↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK130212 Date20 Nov 2013ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 Sep 2026

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

This device is a safety hypodermic needle, designed for the aspiration and injection of fluids in medical procedures. It is intended for use with or without a syringe and is compatible with standard luer slip and luer lock connectors, ensuring secure attachment for safe fluid administration or withdrawal.

The Safety Hypodermic Needles With/Without Syringe are used in general hospital settings by medical practitioners. They are manually activated post-use, with a hinged safety sheath that can be engaged via finger, thumb, or surface contact to prevent needle-stick injuries. Supplied in sterile packaging for single-use, these devices are regulated under FDA 510(k) clearance (K130212) and comply with EU MDR standards.

Other devices from Wuxi Yushou Medical Applicances Co., Ltd.

Questions

AI-generated answers, 18 Sep 2026

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

  • Are these needles designed for reuse, or are they meant to be used only once and then discarded?

    These safety hypodermic needles are strictly single-use only. They come in sterile packaging, ensuring they are uncontaminated for one-time medical procedures. After use, the device should be discarded to comply with infection control protocols and manufacturer guidelines.

  • How do I activate the safety feature on the needle after use, and what are the options for engagement?

    The safety feature is manually activated post-use by engaging the hinged safety sheath. This can be done by pressing with your finger, thumb, or by surface contact, effectively covering the needle tip to prevent needle-stick injuries. This design ensures ease of use while maintaining safety.

  • What types of syringes are compatible with these needles, and how is the attachment secured?

    These needles are compatible with standard luer slip and luer lock connectors, which are widely used in medical syringes. The secure attachment ensures a tight seal for safe fluid administration or withdrawal, reducing the risk of leaks or disconnections during use.

  • Where is this product manufactured, and who should I contact for additional information?

    The product is manufactured by Wuxi Yushou Medical Applicances Co., Ltd. in Wuxi, China. For further inquiries, you may reach out to Garfield Wang, the contact listed for the manufacturer, via the provided address or contact details.