NSC

Injector, Pen

Product code

NSC

Device name

Injector, Pen

Device class

Class 2

21 CFR

21 CFR 880.5860

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).