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Disposable Insulin Pen Needle

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K221178

by Ningbo Medsun Medical Co., Ltd.

Identifiers

510(k) Number
K221178 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)

This device is a disposable insulin pen needle, classified under the nomenclature for single-use injection needles designed for insulin delivery via pen injectors. It is intended for subcutaneous administration of insulin, ensuring precise dosing and minimal patient discomfort during diabetes management.

The needle is supplied sterile, intended for single-use only, and must be discarded after one use to prevent contamination. Authorized under FDA 510K and MDR, it adheres to regulatory standards for medical devices. Available in standard configurations, it requires no special storage conditions beyond a clean, dry environment and is compatible with insulin pen systems.

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: Disposable Insulin Pen Needle-Ningbo MEDSUN Medical Co.,Ltd., Ningbo MEDSUN Medical Co.,Ltd., Disposable Insulin Pen Needle (Standard Type) — NINGBO MEDSUN MEDICAL ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ningbo Medsun Medical Co., Ltd.

Sources (2)

  • FDA 510(k) K221178 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026