NSC

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Injector, Pen

Device class

Class II (moderate risk)

Regulation

21 CFR 880.5860

Medical specialty

General Hospital

FDA definition

A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.

Adverse events (MAUDE)

2016: 38 · 2018: 16 · 2019: 90 · 2020: 34 · 2021: 22 · 2024: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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