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BD Single Use Hypodermic Syringe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110771

by Becton, Dickinson and Company

Identifiers

510(k) Number
K110771 FDA 510(k)
FDA Product Code
FMF 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)

The BD Single Use Hypodermic Syringe is a three-piece manual device classified as a hypodermic syringe under the FDA’s General Hospital category. It is designed for single-use administration or aspiration of fluids in clinical settings, featuring a plastic barrel with graduated markings for precise dosing.

This device is intended for use by healthcare professionals in sterile environments and is supplied as a single-use item. It has received FDA 510(k) clearance under Special Review (K110771) and is manufactured by Becton, Dickinson and Company. No MRI safety or reusable specifications are noted in the regulatory data.

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: BD® Hypodermic Needle and Syringe Solutions | BD, BD® Conventional Needles and Syringes | BD, BD SINGLE USE, HYPODERMIC SYRINGE (K110771) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K110771 24 fields · synced Sep 18, 2026