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Disposable Automatically Retractable Safety Syringes (Detachable Needle)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K222452

by Shantou Wealy Medical Instrument Co., Ltd.

Identifiers

510(k) Number
K222452 FDA 510(k)
FDA Product Code
MEG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a disposable automatically retractable safety syringe with a detachable needle, designed to reduce the risk of needle-stick injuries during use. It falls under the classification of a syringe with antistick features, ensuring safer handling while maintaining functionality for fluid administration or aspiration in clinical settings.

The syringes are intended for single-use in general hospital environments and are supplied sterile. They are classified as Class II medical devices under FDA regulations (880.5860) and have received FDA 510K clearance and MDR authorization. Multiple model references are available, covering various sizes and configurations, and must be stored according to manufacturer instructions to preserve sterility.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shantou Wealy Medical Instrument Co., Ltd.
FDA Applicant
Shantou Wealy Medical Instrument Co.,Ltd

Sources (2)

  • FDA 510(k) K222452 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026