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Sterile Safety Hypodermic Needles for Single Use +2 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K232165

by Berpu Medical Technology Co., Ltd

Identifiers

510(k) Number
K232165 FDA 510(k)
FDA Product Code
FMI FDA 510(k)
Models / Variants
Sterile Safety Hypodermic Needles for Single Use FDA 510(k)EUDAMED
Sterile Hypodermic Needles for Single Use- Disposable Needles FDA 510(k)EUDAMED
Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a sterile, single-use hypodermic needle designed for subcutaneous, intramuscular, or intravenous injections. The self-sealing variant features a protective cap that prevents accidental needle sticks and maintains sterility after use, reducing the risk of contamination or injury. Both disposable and self-sealing variants adhere to the nomenclature for disposable hypodermic needles, ensuring compatibility with standard medical procedures.

The needles are supplied sterile and intended for one-time use only, eliminating the need for reprocessing. They are classified under the FDA’s product code FMI and are regulated under the Medical Device Regulation (MDR) and FDA’s 510(k) pathway, with a determination of substantial equivalence to predicate devices. Available in various gauges and lengths, they are packaged individually to preserve sterility and are suitable for use in general hospital settings, adhering to standard infection control protocols.

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
Berpu Medical Technology Co., Ltd
FDA Applicant
Berpu Medical Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K232165 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026