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Sterile Hypodermic Needles for Single Use

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231720

by Wepon Medical Technology Co., Ltd.

Identifiers

510(k) Number
K231720 FDA 510(k)
FDA Product Code
FMI FDA 510(k)

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)

Sterile Hypodermic Needles for Single Use are sterile, single-use hypodermic needles consisting of a stainless steel needle tube, polypropylene hub, and protective cover. They are designed for fluid injection or aspiration when used with luer lock or luer slip syringes.

The device is operated manually by medical professionals or trained caregivers in hospitals and clinics. It is supplied sterile and intended for single use only. The device received FDA 510(k) clearance (K231720) on September 8, 2023, as a Class 2 General Hospital device with product code FMI through the Traditional 510(k) pathway.

Frequently asked questions

What is the Sterile Hypodermic Needle for Single Use intended for?

It is designed for fluid injection or aspiration when used with luer lock or luer slip syringes, operated manually by medical professionals or trained caregivers in hospitals and clinics.

Is the Sterile Hypodermic Needle for Single Use sterile and intended for one-time use?

Yes, the device is supplied sterile and intended for single use only, as stated in its description, to prevent cross-contamination and ensure patient safety.

What materials are used in the construction of the Sterile Hypodermic Needle for Single Use?

The needle consists of a stainless steel needle tube, a polypropylene hub, and a protective cover, as specified in the device description.

What is the FDA 510(k) clearance number for the Sterile Hypodermic Needle for Single Use?

The device received FDA 510(k) clearance under number K231720 on September 8, 2023, as a Class 2 General Hospital device with product code FMI.

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. Sources consulted: K231720 FDA 510(k) - Sterile Hypodermic Needles for Single Use, Sterile Hypodermic Needles for Single Use (K231720) — FDA 510(k ..., PDF Wepon Medical Technology Co., Ltd. September 8, 2023 ℅ Esther Zhang ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wepon Medical Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K231720 24 fields · synced Sep 28, 2026